Compliance Assurance Specialist - Port Elizabeth Verfied

Salary Negotiable Port Elizabeth, Eastern Cape Port Elizabeth, Eastern Cape more than 14 days ago 07-10-2015 1:00:01 PM
04-11-2015 1:00:01 PM
Requirements:
- Grade 12
- Scientific or Quality diploma / degree or equivalent
- Minimum 1 to 2 years' experience in a pharmaceutical / QA environment
- Good working knowledge of GMP
- Computer literate - intermediate level knowledge essential
- Managerial / leadership qualification will be an advantage
- PMA or pharmaceutical qualification will be an advantage
- BAAN experience will be an advantage
- Must be willing to work shifts and overtime

Responsibilities:
- Plan and co-ordinate activities as per scheduled manufacturing and packing of third party products in the facility
- Implement contingencies to the plan as and when required
- Propose recommendations for improvements to the plan
- Prioritize the workload to ensure that all task are completed on time
- Ensure constraints are prioritized according to relevant classification and resolved timeously
- Ensure quality and GMP standards are maintained
- Anticipate and prevent deviations and non-compliances before they occur
- Conduct investigations and root cause analysis of non-conformances by using appropriate problem solving techniques
- Evaluate the non-conformances identified on a daily basis and liaise with management regarding
- Ensure third party SOP's are maintained and strictly adhered to
- Ensure inspection of GMP compliance during manufacturing and packing operations of third party products
- Inspection of batch documents during manufacturing and packing operations
- Provide training on batch documentation completion
- Plan, perform and report on internal audits of the facility on a regular basis to establish GMP contraventions and systems breakdowns
- Present audit non-compliances to management
- Recommend, evaluate, institute and follow up on corrective actions on audits
- Monitor effectiveness of corrective actions to prevent recurrence
- Continuously review processes and documentation for improvement

Recruiter: Jobs2day,PE