
Website Aspen Pharma
Job Description:
To monitor manufacturing compliance to GMP and statutory requirements, monitor adherence to guidelines, procedures and document controls, deliver expected productivity targets as per business requirements, related administrative tasks as well as serve as back up to Team Leader on shift.
Job Responsibilities:
- Manage and resolve customer complaints
- Drive CAPA investigations in area of focus
- Verify IPCs are in line with product quality and specifications
- Optimise processes and identify gaps in policies/ procedures
- Determine, request and use resources/ assets optimally
- Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
- Manage, review and approve change control programs and deviations/ concessions comply to standards and specifications
- Ensure production process adherence to standards and specifications
- Plan and prioritise daily, weekly and monthly activities
- Perform, review and approve line sign-on’s, closures and clearance authorisations
- Audit logbooks and systems
- Verify good document practice as per SOP and regulation
- Investigate deviations and concessions, and assess risk
- Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
- Raise deviations and implement corrective action
- Raise maintenance notifications as and when required
- Perform, review and approve batch reconciliations to product specifications and quality
- Review and approve preliminary batch records
Job Requirements:
- Registration with Pharmacy Council
- Ability to interpret and implement policies, processes and objectives
- Minimum of BPharm degree
- 1-3 years’ related work experience
- Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
- Pharmaceutical manufacturing experience
Job Details:
Company: Aspen Pharma
Vacancy Type: Full Time
Job Location: Port Elizabeth
Application Deadline: N/A
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