Pharmaceutical concern is seeking a Senior QA Specialist to join their Quality Assurance Operations team. Responsibilities:
- Review and approve minor and major deviations and escalate critical deviations to the manager
- Review and approve CAPA in order to meet compliance requirements.
- Review and approve minor and major change controls for quality and regulatory compliance impact and determine requirements for implementation.
- Coordinate and participate in risk assessments and ensure mitigations are efficacious when applicable.
- Review and approve SOPs and Work instructions for responsible areas.
- Review, approval and sign-off all operational documents and records, e.g. periodic re-qualification, periodic-revalidation including both Protocols and Reports to ensure compliance with site approaches, cGMP and regulatory agency requirements.
- Act as a QA lead on critical deviations, investigations, Risk assessments and Root cause Analysis as required.
- Ensure that the activities in the Quality Assurance Department are achieved at the required quality levels (SA GMP, PIC/s and WHO).
- Analyse and write annual trend reports where applicable.
- Support Quality Assurance with customer audits, Regulatory audits and other 3rd party audits; perform internal and supplier audits and compile audit reports; assist HOD and Manager on follow up and close out of audit findings timeously.
- Ensure compliance to all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining way of working.
- Participate in achieving the company’s quality objectives.
- Participate in building a sustainable quality culture on site and proactively mitigate risks that may negatively impact quality or escalate these appropriately.
- Ensuring audit readiness within own role through closing out audit findings timeously.
- Participate in projects as/ when required.
- Ensure project deliverables delivered as per agreed timelines and quality.
- Key decision maker on quality aspects of allocated projects
Ensure quality by design, risk-based approach and risk assessments conducted and mitigated where appropriate in accordance to project timelines.
- Ensure Change management, Risk management are incorporated into all allocated projects.
Please note only shortlisted candidates will be contacted
- At least 5 years’ experience in Quality Assurance within the pharmaceutical/ biotech/API manufacturing industry
- Sound technical ability in the field of operational Quality Assurance.
- Experience in quality management systems within a sterile manufacturing cGMP facility.
- Quality and Regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO as well as application.
- Project management in Quality Assurance
- Sound application of risk management and technical report writing
- Understanding of Validation & Qualification principles, Quality by design principles.