Latest Jobs at Aspen Pharma Group

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 ensure continued compliance at all times
• 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 and 10 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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Overview

 Assist in the testing of all drugs and materials.

Sample testing before storage

• Coordinate the unpacking of the boxes to acquire the sample, as per the sampling plan for materials.
• Sample content according to required specifications.
• Check the repacking of the box for stocking (e.g., wrapping) according to directions.

Sending samples to lab

• Complete sampling sheets
• Send completed sampling sheets to Quality Control

Sample testing after storage

• Pick the material and request it be brought to the testing area.
• Sample content by required specifications.
• Check the repacking of the box restock.

Raw material dispensing

• Receive job orders in the system.
• Locate and pick the pallet.
• Place the job number on the pallet.
• Update the status of the job order into the SAP system.
• Secure the load.
• Dispense the material.
• Move the load to the ready area or shipping area.

Planning and Procedures

• Prioritize and execute responsibilities effectively for a single technical area.
• Prioritize daily work to complete tasks / projects assigned by others.
• Work within established policies, practices, and guidelines as well as established quality and safety checks.
• Work is periodically reviewed by others for compliance, quality and accuracy.

Asset/Resource coordination

• Determine resource needs within our own are of responsibility.
• Request required assets and resources for the fulfilment of work duties.
• Use assets and resources optimally within own area of responsibility.

Technical expertise

• Optimise own work processes.
• Identify gaps in current policies, procedures, and legislation as it relates to own area of work.
• Facilitate implementation of processes in own area of work 

Reporting and record keeping

• Provide information for completion of reports.
• Maintain and update records and systems as required.

Requirements

Background/experience

• 2-4 years in a pharmaceutical environment
• Minimum National Certificate (N4-N6)

Competencies

• Interrogating Information
• Meeting Deadlines
• Customer Awareness

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Job purpose

• Manage and coordinate validation testing to support tech transfers.
• Manage and coordinate laboratory specifications & testing methods.
• Provide analytical, maintenance and QC lab support.
• Ensure continuous compliance of lab with GMP standards.
• Ensure that products are produced, tested and stored according to the required SOP’s and documentation.
• Performance management of direct reports.

Responsibilities

Planning and Section Management

• Provide input into operational planning of section, and prioritization of objectives.
• Provide input into, interpret and execute policies and procedures.
• Provide input into and manage budgets and resource requirements for section.
• Provide section staff with day-to-day direction and tasks.

Validation testing to support technology transfers.

• Manage and monitor compliance of QC lab testing activities to GMP, quality standards, and product specifications.
• Manage and coordinate lab preparation activities according to SOPs (samples, working area(s), PPE and lab equipment)
• Prepare and implement maintenance and calibration schedules and records.
• Ensure set priorities and targets are achieved, identifying constraints and solutions.
• Investigate and report Out of Specifications (OOS)
• Enforce Good Lab Practice

Specification upgrade and maintenance

• Manage and coordinate specification preparation, upgrade and maintenance projects according to SOPS and project plans.

Lab Quality Reviews & Training

• Validate batch documentation approvals.
• Review and approve corrections in batch documentation.
• Identify and coordinate training of staff on SOPs.

Deviations Investigations

• Manage and coordinate deviation investigations and reporting.
• Coordinate and initiate risk/ impact assessments and plans to address quality deficiencies.
• Manage implementation of operational changes to SOPs and processes.

Governance, Risk & Compliance

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

Requirements

Skills Required

Background/experience

• Bachelor's degree in chemistry or microbiology with 5 years’ related experience
• Laboratory and Good Laboratory Practice experience
• Supervisory experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods and analytical method verification / transfer testing
• Knowledge of value chain and MCC principles
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives.

Competencies

• Interrogate Information
• Managing Performance
• Planning and Organizing
• Customer Awareness

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Description

• Fine Chemicals requires the services of a highly competent QC Lab Analyst for the Quality Control Department.  To qualify for this position suitable candidates must fulfill the following requirements.

Requirements

JOB REQUIREMENTS:   

• Minimum Educational requirement is a Formal Tertiary Qualification in Chemistry - National Diploma or BTech. An Equivalent Qualification as per the National Qualifications Framework (NQF) - SAQA would be considered.
• Minimum of 1 years’ experience in a pharmaceutical laboratory.
• Thorough knowledge and understanding of cGMP (current Good Manufacturing Practice) and the manufacture of Active Pharmaceutical Ingredients (APIs).
• Must be computer literate, MS Windows, i.e. Word, Excel, Outlook PowerPoint, etc.
• Good practical and theoretical knowledge of analytical chemistry.
• Proven problem-solving skills and techniques.

BASIC JOB FUNCTIONS (Brief Summary):             

• Analysis of equipment cleaning samples, raw materials, in-process, and final bulk product samples according to standard operating procedures and test methods.
• Chemical and Endotoxin testing of Purified Water.
• Assist and sampling of Purified Water when required.
• Carry out analysis and activities in a safe manner in accordance with OHSE and Good Laboratory practice guidelines.
• Analytical support to production as and when analysis feedback is required on samples.
• Complete analysis on time as per set target times and dates.
• Able to work shifts and weekends on a rotational basis.
• Ensure tasks are performed in a manner that is compliant with Good Laboratory Practice and that other Regulatory guidelines are adhered to.

PERSONAL ATTRIBUTES (Brief Summary)            

• Good organizational skills, with a hands-on and honest approach.
• Good interpersonal skills.
• Exceptional attention to detail and accuracy.
• Good communication (written and verbal) and excellent report-writing skills.
• Ability to critically evaluate data and work under pressure.
• Ability to perform tasks concurrently even if it means working late or overtime.