Fresh Jobs at Aspen Pharma Group

Description
Overview

• Control and manage validation function to ensure equipment is validated in compliance with GMP/ regulatory requirements
• Provide technical support, process control and process improvement activities to support validation activities
• Manage and guide the unit through team leaders
• Performance management of direct reports and unit

Responsibilities

• Planning and Unit Management
• Provide technical and operational input during the drafting of processes, policies and procedures for unit
• Monitor implementation of operational plan by team
• Manage operational budget of the unit
• Ensure availability and optimal allocation of resources to achieve operational objectives
• Perform human resource functions for optimal management of unit
• Validation
• Ensure validation plans, SOPs and protocols are compiled and implemented to always ensure continued compliance
• Manage validation activities within value stream validation programme according to validation plan/ schedule
• Evaluate results from executed validation protocols
• Ensure validation protocols and validation reports for new equipment / systems are documented and compiled
• Develop and implement re-validation plans
• Maintain and audit compliant state of validation department
• Review validation training requirements and implement training where necessary

Qualification

• Manage qualification activities with QC and Production
• Review and approve relevant qualification protocols as per SOP
• Manage change controls to ensure compliant status of affected equipment is not compromised
• Ensure documents and procedures to operate and maintain equipment are in place

Requalification

• Review and approve re-qualification of equipment and utilities as per Protocol and SOP
• Governance, Risk and Compliance
• Oversee compliance within strategic and operating guidelines and policies for department(s)/ function(s)
• Ensure recordkeeping complies with legal requirements and provide input into changes to policies in this regard
• Provide recommendations for development of risk-based compliance systems in order to improve overall compliance performance of the organisation and/or department/function.

Requirements
Background/experience

• Minimum of Bachelor’s Degree and10 years’ related experience
• Management experience
• Experience in validation techniques in a Pharmaceutical Industry

Specific job skills

• Advanced understanding of Qualification and Validation principles
• Knowledge of control, instrumentation and electrical systems
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Translating strategy
• Interpreting and internalising information
• Interrogating information
• Offering insights
• Managing performance

Accountability & Decision Rights

• Develop, communicate, manage and implement corporate and divisional strategic plans and budgets, policies and procedures
• Independent Decisions relating to
• Design and implementation strategy for programmes and processes
• Interpretation and execution of and recommendations on policy/ procedure related modifications
• Short- and long-term department schedules, quality, compliance and resource allocation
• Operational objectives and work plans, and delegation of assignments

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Description

• Fine Chemicals requires the services of a highly competent Regulatory Affairs Scientist for the Regulatory Affairs Department.  To qualify for this position the most suitable candidate must fulfil the following requirements.

Requirements

JOB REQUIREMENTS:

• Degree in Chemistry/Pharmaceutical Sciences or equivalent qualification.
• Good knowledge of chemistry (Analytical and Organic).  Knowledge of local and international pharmaceutical regulations and guidelines would be highly advantageous.
• Excellent written and verbal communication skills and the ability to interact well with internal and external customers.
• Minimum of 3 years’ experience in pharmaceutical, cGMP, or chemical manufacturing environment.
• Proven technical documentation compilation skills, with the ability to critically evaluate and interpret data.
• MS Office computer literacy, particularly the following applications: Word, Excel, Outlook, Teams, Access and PowerPoint.  Minitab and/or EXTEDO proficiency would be advantageous.

JOB FUNCTIONS (Brief Summary)

• Compilation and update of documents to be submitted to Regulatory Authorities.  This includes the compilation of Common Technical Documents (CTDs) in accordance with relevant guidelines and regional requirements.
• Compilation, update and/or amendment of internal documentation relating to the testing and manufacture of Active Pharmaceutical Ingredients (APIs).
• Responding to customer (both internal and external) and regulatory authority queries.
• Ensuring that annual product quality reviews are compiled according to cGMP standards and adverse trends and potential process improvements identified.
• Implementing changes according to established company procedures relating to the testing and manufacturing process.
• Compilation and/or update of manufacturing and cleaning instructions according to internal procedures and in line with regulatory expectations.
• Compilation of process qualification protocols and reports.
• Ensuring that related databases are updated to allow for the capturing of API data.

PERSONAL ATTRIBUTES (Brief Summary)

• Good interpersonal skills.
• Good organisational and systems implementation skills.
• Exceptional attention to detail and accuracy.
• Good communication (written and verbal) with excellent report writing and document reviewing skills, including the ability to evaluate data critically.
• Ability to perform tasks concurrently.

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Description
Overview

• Manage and supervise the manufacturing/packing of products
• Manage production frontline staff and drive shift production performance against key metrics
• Ensure production problems are identified and solved
• Deliver planned production output and achieve plan adherence goal
• Deliver operational efficiencies and reduce unplanned downtime
• Performance management of direct reports, monitoring of performance management within section 
• Support pharmaceutical responsibility, if a qualified pharmacist

Responsibilities

• Planning and Section Management
• Provide input into operational planning of section, and prioritisation of objectives
• Provide input into, interpret and execute policies and procedures
• Provide input into and manage budgets and resource requirements for section
• Plan daily and weekly activities of section
• Provide daily coaching and supervision for section
• Manage staff performance to achieve right efficiency, good quality and SHE goals through company performance management
• Implement top loss and waste management programs, to achieve targets

Production Preparation

• Monitor the execution of production plans and take corrective measures where necessary
• Obtain support from Functional Heads to meet Production targets, where required
• Develop and implement contingency plans to manage risk
• Prepare shift and overtime schedules
• Conduct pre-shift and handover meetings
• Plan changeovers with Engineering and Maintenance to ensure operational efficiency
• Review equipment/ machines on shift to ensure optimal efficiency
• Ensure that production score boards are updated daily

Compliance Checks

• Ensure GMP and GDP compliance of Production operations
• Monitor room performance to compliance requirements
• Perform checks to ensure correct setup and operation of equipment and cleanliness of Plant as per SOP

Governance & Risk

• Provide input for improvement of risk-based compliance systems
• Monitor implementation and correct own and/or team compliance with legislation, policies and procedures

Requirements
Skills Require

Background/experience

• National Diploma in Engineering/ Chemistry/ Operations with 5 years’ related experience
• Pharmaceutical manufacturing experience
• Project Management experience
• Supervisory experience

Specific job skills

• Advanced knowledge and understanding of Pharmaceutical manufacturing, TPM/Operational Excellence and Lean Manufacturing
• Problem solving and solution engineering
• Pharmaceutical standards and compliance requirements
• Coaching, leadership and mentoring
• Ability to interpret and implement policies, processes and objectives

Competencies

• Managing performance
• Planning and organising
• Meeting deadlines
• Finalising outputs
• Taking action

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Description
 Overview

• Review and approve batch documentation in line with SOP and quality standards
• Perform lab quality review in line with SOP
• Provide services according to Production plan
• Related administrative tasks

Responsibilities

Planning and Operational Support

• Oversees work and/ or serve as a lead technical expert
• Optimise and facilitate implementation of current processes
• Identify gaps in current policies and procedures
• Propose changes or improvements to processes, tools and techniques
• Provide information for reports, as required by superior
• Provide analytical support in the absence of the TL
• Provide support during regulatory audits.

Lab Quality Review

• Perform LQRs according to Production plan
• Review and approve lab records to ensure pharmaceutical analysis has been carried out as per MOA; direct queries to laboratory
• Electronic approval of analytical results on relevant software. e.g. Empower
• Evaluate and interpret chromatography data to ensure accuracy of results.
• Review and approve batch documentation compliance with SOPs and quality standards
• Correct errors in batch documentation, in line with GMP standards, SOPs, and product specifications
• Record all OOS investigations and conclusions, and report to management
• Provide advise to analysts during laboratory investigations.
• Provide input into SOPs
• Ensure that products are produced, tested and stored according to the required SOP’s and documentation
• Ensure adherence by Analyst/ Tester before release

Reporting and Record-Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis
• Analyse consolidated data and provide recommendations
• Compile detailed and standardised reports and consolidated documents
• Initiate deviations once picked up during reviewing.

Requirements
Skills Required

Background/experience

• National Diploma in Analytical Chemistry with 6+ years experience
• Laboratory experience

Specific job skills

• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives
• Strong technical knowledge and be competent in the use of all laboratory equipment, software and techniques.

Competencies

• Interrogating information
• Following Procedures
• Maintaining Accuracy
• Customer Awareness

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Description
Overview

• Perform QC and stability tests on raw materials, in-process and finished products, components and water to ensure quality and compliance
• Review compliance of products to GMP, quality standards, and product specifications
• Provide services according to Production plan

Responsibilities

Planning and Operational Support

• Optimise and facilitate implementation of current processes
• Propose changes or improvements to processes, tools and techniques

Test Preparation

• Prepare and analyse samples according to SOPs
• Prepare and operate laboratory equipment according to SOPs
• Perform calibration checks on equipment according to calibration procedure, to ensure accurate results
• Prepare reagents and solutions for testing
• Maintain good housekeeping

Testing

• Perform HPLC/GC analysis using MOA
• Perform routine analysis on in-process and final products, raw materials and components
• Perform routine stability tests such as related substances, assay and dissolution to assess quality of product
• Perform daily and weekly water testing according to SOP
• Support testing for OOS investigations to establish any systematic issues in process or testing
• Handle problems efficiently according to quality policy
• Report feedback on services or outputs regularly to customers
• Check HPLC/GC runs regularly during the shift
• Provide internal customers with accurate HPLC/GC results
• Propose, develop and update methods for improving customer service
• Check, document and report operational output against actuals
• Communicate deviations for production and process improvements
• Utilise technology as per qualification requirements

Reporting and Record-Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis
• Analyse consolidated data and provide recommendations
• Record, interpret and report testing results to management, including OOS result

Requirements
Skills Required

Background/experience

• National Diploma in Analytical Chemistry with 2+ years experience
• Laboratory experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods
• Understanding of pharmaceutical manufacturing and corrective action programs
• Knowledge of Millennium Software (HPLC) and GC Software
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Interrogating information
• Meeting deadline
• Following Procedures
• Maintaining Accuracy
• Customer Awareness