
Website Aspen Pharma
Job Description:
Interpret and implement quality procedures, standards and specifications for value streams. Manage and coordinate value stream QA activities. Coordinate and execute the review and approval of in-process quality programs. Manage and coordinate admin functions within quality systems. Performance management of direct reports. Perform activities for process compliance and product release, when required.
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Job Responsibilities:
- Provide input into budget and resource requirements of section
- Perform batch release when required
- Completion and monitoring of time and attendance
- Verify batch release conditions and documentation
- Monitor implementation and correct compliance with legislation, policies and procedures
- Run effective performance review meetings
- Issue, track and approve CAPA requests
- Attend L1-2 meetings
- Provide section staff with day-to-day direction and tasks
- Manage implementation of operational changes to SOPs and processes
- Leading deviations related to country requirements
- Ensure visual performance boards are updated
- Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
- Manage and coordinate batch release priorities in line with On Time In Full (OTIF) and planning schedule requirements
- Request and allocate assets and resources for the fulfilment of work objectives and monitor their use
- Manage and coordinate process to determine disposition of products
- Manage and coordinate process compliance activities to ensure that batch release is consistent with OTIF and planning schedule
Job Requirements:
- Minimum 4-6 years’ related work experience
- Pharmaceutical standards and compliance requirements
- Strong working knowledge of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical manufacturing experience
- People management
- Ability to interpret and implement policies, processes and objectives
- Minimum of B Pharm
Job Details:
Company: Aspen Pharma
Vacancy Type: Full Time
Job Location: Port Elizabeth
Application Deadline: N/A
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