Current Vacancies at Aspen Pharma Group

Description

Provides technical / scientific / documentation input for internal and external technology transfer of manufacturing processes. Troubleshoots problems encountered during tech transfer/process optimization. Supports process validation activities and provides input on regulatory queries.

 Responsibilities

Planning and project support

• Research and report on solutions to improve tracking, planning and collaboration.
• New product introduction assessment
• Technical evaluation of products and processes
• Draft transfer protocols, project plans and timelines and prepare proposals and status reports.
• Compile technical documents that comply with local and international regulatory guidelines.
• Support technology transfer team activities and projects
• Identify project issues and recommend methods for resolution.

Project management

Support aspects of tech transfer projects, including:

• Feasibility and risk assessments
• Planning
• Trial and validation batch manufacturing
• Execution and tracking

 Manufacturing science, technology

•     Execution of lab-scale and trial batch manufacture.
•   Assist with execution of validation batch manufacture.
• Provide input regarding process changes and process optimization, including API source changes where relevant.
• Support life cycle approach to product introduction.
•   Troubleshoot process / product problems.

 Risk management

•  Conduct feasibility and quality risk assessments according to local and international regulatory requirements.
•  Ensure that project planning encompasses quality, risk and process validation aspects.
• Ensure data integrity and regulatory compliance throughout tech transfer processes.
•  Carry out investigations associated with tech transfer activities.
• Support Process Qualification (PQ) activities to validate transferred processes.

Requirements

Background/experience

• 4 to 6 years’ experience, with at least two years in a pharmaceutical manufacturing environment
• Bachelor’s degree in pharmacy, Engineering or Similar

Specific job skills

• Knowledge of Pharmaceutical technical issues, manufacturing processes and operations environment
• Knowledge of validation, regulatory affairs, R&D, and new product transfer
• Knowledge of local and international pharma guidelines

Competencies

• Offering Insights
• Investigating Possibilities
• Innovative Thinking
• Technical/scientific report writing.
• Data analysis

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Objective: 
To perform pharmaceutical functions within the Release sub-department of the QA department. This involves review and release of products according to GxP and company Standard Operating Procedures.

KEY RESPONSIBILITIES

GENERAL OPERATIONAL ACTIVITIES

• Execute daily tasks and work instructions according to the relevant SOP's.
• Operate computer systems by capturing data, printing standard reports, etc.
• Perform reconciliations of data
• Update and maintain databases
• Edit and format SOP's as and when required.
• Generate reports as per instruction
• Verify and interpret the accuracy of data and audit documentation
• Ensure that all relevant documentation gains the necessary signatures for completion
• Maintain accurate filing and retrieval of documentation
• Perform any other tasks reiating to your work as and when required

FINAL RELEASE OF ALL EXTERNAL SUPPLY PRODUCTS

• Review of batch documentation, i.e. Executed batch documents, Post-lmportation test results, ete. for compliance to GMP and master documents as per product dossier.
• Review of product samples and artwork, where applicable for SA Markets.
• Ensure that Post lmportation Testing (PIT) (where applicable) is being adequately managed.
• Monitoring blocked stock at the different warehouses on continuous basis.
• Ensure product release is conducted as per SOP for SA and lnternational Markets.
• Management of product re-works according to SOP and cGMP.
• Review of data logger downloads for product's received in country
• Ensure batch release by OTIF commitment dates.

INVESTIGATING AND RESOLVING QA QUERIES

• Conduct and request feedback and/or reports on QA queries from Manufacturer and discuss with QA Management team.
• Follow up on outstanding documentation such as reports and deviations.
• Approval of deviations and logging deviations received from CM in consultation with QA management team
• Management of laboratory Out of Specifications in consultation with the lab and CM
• Handling of Suspect Stock Notifications from the Aspen / 3PL warehouses to ensure they are investigated correctly and do not recur.
• Review of temperature excursions for products during transportation or storage from manufacturer, distributors, or customers in consultation with QA Management team.
• Review of raw materials status at the CM in terms of expiry date, re-testing, ete. as per SOP and assisting in resolving any queries regarding RM's
• Updating of SAP system with regards to expiry date of stock, where applicable.

CONTROL OF HIGHLY SCHEDULED SUBSTANCES

• Completion of 56 requisitions for samples requested.
• Logging of samples received in the 56 register.
• Balance of 56 Register as per Medicines Control Council (MCC) / SAHPRA requirements.
• Applying for Import permits/authorisation for all Schedule S and 6 medicines handled by the External Supply (ES) department for the SA market.
• ldentifying new products to be launched that will require a permit and performing the necessary set-up with the SAHPRA.
• Conducting regular meetings with the Commercial / Demand Planning department to ensure that all 55 and 56 medicines coming into SA have permits.
• Ensuring that the permits are customs cleared once the product is in country, performing the necessary reconciliation and sending the permits back to SAHPRA / MCC as per agreed timelines.

MANAGEMENT OF QA ACTIVITIES FOR NEW PRODUCT LAUNCHES AND RE-ALIGNMENTS

• Requesting Finished Product Testing documents from Regulatory Authority (RA) department and providing these to the potential PIT labs for quotation.
• Assisting in resolving any queries arising with PIT lab and RA / Aspen technical team.
• Reviewing the PIT quotations from the labs and advising the QA manager as to the most appropriate option.
• Co-ordinating the Analytical Method Transfer (AMT) with the selected PIT laboratory for New product launches and re-alignments, where required.
• Oversee that the Reference standards, Columns, and other materials needed by the PIT lab are ordered timeously to prevent delays in testing of new launch products.
• Ensuring the master documents and executed documents are requested and received timeously from the supplier as part of the launch/re-alignment process.
• Review of the full batch documentations for the 1st two batches of a new product launch or re-alignment for compliance to GMP and product dossier.

QMS METRICS - SOP's, DEVIATIONS & CHANGE CONTROLS AND REPORTING

• lnitiation and review of SOPs relevant to work function.
• Completion of the sections in the QSMR relevant to batch release and lab management.
• Logging of internal deviations on the QAlign system and management thereof to ensure that adequate CAPA's are in place to prevent future recurrence on non­ performances.
• Review of external deviations and making recommendations as to actions to be taken.
• Completion of action items assigned on Change Control on QAlign system.
• Performing internal audits as and when required.
• Compiling AD-hoc reports as and when required

CONTINUOUS IMPROVEMENT INITIATIVES

• Identify gaps within the current processes and investigate and propose ways to close those gaps
• Identifying ways to streamline processes, resulting in quicker turnaround of QA activities.
• Manage projects assigned to you as per guidelines from the manager and as per agreed timeframes.
• Regularly provide feedback on progress of projects and highlight any issues that require manager's attention.

HUMAN RESOURCES

• Compliance to Labour Legislations and ln-house Best Practice).
• Familiarize yourself with and at all times act in accordance with the company policies and procedures.

GMP COMPLIANCE

• Complete all records and reports timeously and accurately as described in the relevant SOP's, protocols and associated documentation.
• Comply with GMP/GLP requirements as outlined by company SOP's and written instructions in all tasks and activities.
• Ensure that products are handled according to the required SOP's and documentation.

HEALTH, SAFETY AND ENVIRONMENTAL STANDARD

• Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment.
• Report any unsafe or unhealthy situations to SHE representative or Line Manager
• Report any incident to the SHE representative or Line Manager which may affect your health or cause injury

Requirements

EDUCATION & EXPERIENCE

• Matric/Grade 12
• Bachelor in Pharmacy
• Registration with South African Pharmacy Council {SAPC)
• Computer Literate - MS Word & Excel
• 1-2 year experience in Pharmaceutical environment
• Pharmaceutical Manufacturing experience

KNOWLEDGE: 

• Sound knowledge of Good Manufacturing Practice
• Strong working knowledge of pharmaceutical manufacturing
• Pharmaceutical standards and compliance requirements 
• People management 
• Ability to interpret and implement policies, processes and objectives
• Good Documentation Practices

SKILLS AND ATTRIBUTES:

• Good verbal and written communication skills
• Professional presentation
• Time Management
• Ability to multitaskand strong proven follow-up skills is a requirement
• Planning and organizing skills
• Good interpersonal skills
• Problem solving/analytical skills
• Interrogating Information
• Customer Focused and Production
• Finalising output
• Accuracy& Tenacity 
• Can do attitude
• Motivated, flexible and able to work within a team-orientated environment
• Ability to follow instructions
• Trustworthy
• Ability to work under pressure
• Attention to detail
• Managing Performance

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Overview

• Lead, manage and prioritise Electrical, Electronic, Automation and Process operations to achieve operational objectives
• Maintenance and asset care planning and execution of electrical and C&A equipment
• Lead improvement and optimisation strategies for elec. infrastructure 

Responsibilities

Planning and Procedures

• Provide input into and implement systems, procedures, and policies
• Plan team activities and advise on prioritisation of activities
• Provide input into and manage budget, as delegated by manager
• Ensure availability of, allocate and monitor use of assets/ resources
• Perform relevant HR / supervisory functions
• Identify gaps in current policies, procedures and legislation and propose process, tool, technique and product changes/ improvements

Electrical Engineering & Calibration and Maintenance

• Facilitate, implement, and manage Elec, C&A & CAL projects
• Identify and motivate for technical CAPEX projects
• Ensure integrity and reliability of production system architecture
• Develop fault finding procedures, installation and document standards and instrumentation protocols
• Maintain, back up and ensure integrity of production data
• Perform maintenance on electrical infrastructure
• Lead RCFA for incidents to identify true root cause of failures
• Lead CAPAs; address operational risk of electrical root cause failures
• Lead development of a systematic Elec, C&A & CAL infrastructure maintenance strategy to optimise operations, reduce operation downtime and associated cost due to failures
• Identify and implement operational and maintenance changes to address specific process unit problems
• Develop and coordinate and monitor implementation of preventative maintenance and calibration plans/ programs
• Determine critical spares requirements for the plant

Governance, Risk and Compliance

• Ensure electrical maintenance is performed in accordance with relevant regulations, policies, procedures, schedules, and work orders
• Manage and review Certificate of Compliance for new and existing electrical installations
• Record and ensure availability of technical drawings, programs and specifications documentation
• Monitor and correct own and/ or team compliance with legislation, policies and procedures
• Monitor and control storage and access to information, and set-up of electronic databases to ensure legal compliance
• Maintain records of asset care documentation

Requirements

Background/experience

• Minimum of National Diploma in Mechatronics /Electrical /Electronic Engineering with 6+ years’ related experience
• Experience in factory maintenance and fault finding in Pharmaceutical Manufacturing  

Specific job skills

• Advanced knowledge of maintenance and monitoring programmes, tools, techniques, and systems
• Specialised knowledge of Instrument and Control calibrations
• Knowledge of pharmaceutical manufacturing, standards, and compliance requirements
• Advanced technical background in Good Engineering Practices
• Ability to interpret and implement policies, processes, and objectives

Competencies

• Interrogating Information
• Offering Insights
• Finalising Outputs 

Accountability & Decision Rights

• Departmental and/ or project related results, costs, methods, staffing, managerial planning, and integration
• Working on and leading complex and high impact projects, serving as a team leader, technical advisor, or process owner
• Deliver service or support at the expert level
• Independently implement appropriate policies and procedures
• Escalate out-of-policy matters 

Decisions related to:

• Products, services, implementing new programmes and supporting technical/ operational processes
• Use of resources to meet defined objectives and timelines
• Initiation of changes to processes, procedures and policies that impact immediate operations
• Non-routine issues and daily priorities for a work group, with moderate impact on operations within a department
• Correction and/ or containment of errors of significant impact (financial loss, customer business, downtime)

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Description

• Provision of business support on all aspects of the area’s work
• Coordination and execution of administrative functions within the Vendor area

Requirements

Permit Management

• Management of permit applications for Aspen SA Operations with SAHPRA
• Support annual submissions of narcotics and psychotropics to SAHPRA.
• Provide quarterly reports to SAHPRA on outstanding Triplicates.
• Ensure expeditious receival of import and export permits/authorizations.

Administrative support

• Assist with the qualification requirements for service providers.
• Provide input into work activities and priorities for the unit.
• Monitor adherence to schedules, organize and schedule meetings, monitor Vendor Management activities, and plan and make travel arrangements.
• Prepare, compile, and release documentation to external departments, example qualification statements.
• Coordinate project and office services
• Performs advanced administrative, operational, customer support and computational tasks.

Process compliance (CAPAs, change, controls, deviations)

• Administer CAPAs requests.
• Coordinate the required tracking of change requests to SOPs and processes and assist in determining compliance with control process.
• Assist in analyzing deviation trends.
• Coordinate the required tracking of overdue CAPAs, CCs, deviations and internal audit reports and responses.

External audits management

• Arrangement for local and international audits
• Coordinate audits relating to document and information management.
• Coordinate and provide support during external and customer and statutory external audits.

Management review, reporting and record-keeping

• Assist in tracking and reporting on in-country Vendor Management metrics.
• Assist in the gathering and consolidating/ compiling information required for reporting.
• Consolidate documents.
• Maintain and update records and systems as required.
• Retrieve documentation and records to facilitate query resolution.

Stakeholder relations

• Communicate with internal stakeholders to achieve work objectives, maintain relationships and to assist and convey information.
• Schedule meetings with local suppliers

Requirements

Background/experience

• 2 to 3 years of relevant experience with permits applications and international travel arrangements
• Grade 12 Certificate
• Knowledge of international travel arrangements essential (55% of responsibility) Knowledge of permit applications with SAHPRA

Specific job skills

• Broad working knowledge of concepts, terminology, and specialized admin requirements to support Vendor Management
• Knowledge of international travel arrangements essential

Competencies

• Information Gathering
• Following Procedures
• Planning and Organizing
• Meeting Deadlines

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Description

• Fine Chemicals requires the services of a Teamleader for the Production Department. To qualify for this position the candidate must fulfil the following requirements.

Requirements

      JOB REQUIREMENTS:   

• Minimum educational qualification Matric /Grade 12 with mathematics and Science or Biology with a pass in both instances and/or equivalent qualification as per national qualification framework levels - SAQA.
• Must have an aptitude for process understanding and work with your hands.
• Must have the ability to be trained and of good health.
• 5 years of relevant working experience as a process operator in a manufacturing plant.
• Be able to form part of the emergency response team (i.e., firefighter, first aider, evacuation warden, or H&S representative).

BASIC JOB FUNCTIONS: 

• To become conversant in the operation of production equipment/machines according to set procedures and work instructions.
• Understand and comply with all relevant SOP’s and work instructions.
• To follow instructions as guided by the Production Supervisor.
• Lead and manage fellow production operators.
• Performs regular housekeeping duties to ensure a clean and healthy work environment according to current good manufacturing practices (cGMP) requirements.
• Understand and comply with relevant health, safety, and environmental procedures whilst performing his/her duties.
• Participate in driving production performance (KPIs).
• You will be required to operate all production equipment according to the set procedures.
• Drive operational excellence in production.
• Responsible for running the manufacturing process centre in line with cGMP and QMS.
• Manage inventory through stock-take processes.

PERSONAL ATTRIBUTES:

• Good communication skills.
• Must be able to work and perform under pressure in a highly regulated environment.
• Must be numerate and show attention for accuracy.
• Must be of sober habits and be willing to work shifts and overtime as operationally required.