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Job Summary
Qualifications and Requirements- Open to work weekends and extra time occasionally
- Qualified Pharmacist
- Interpret, implement, and coordinate systems, processes, policies and procedures contributing to the quality assurance in the unit.
- Provide input into existing systems, procedures and policies that impact in-process control activities in value stream operations and quality in the unit.
- Review and approve operational changes to SOPs and processes.
- Review and approve process for in-process quality management.
- Review and approve process to release disposition of products.
- Lead change overs, line openings and line closings.
- Check weighing of raw materials used for manufacturing purposes.
- Enforce Standard Operating Procedures (SOPs).
- Updating of SOPs.
- Training of production staff on SOPs and cGMP (where required).
- Ensuring that production runs according to the Production Plan.
- Accountable person for GMP compliance in the area.
- Handling of non – conforming Production/Packaging.
- Auditing batch documents for QA closure and release.
- Lead the process of Annual Product Quality Reviews.
- Prepares for audits and ensure compliance to standards.
- Initiate, review and close off CAPAs and Non-Conformances after systematic issues was addressed.
- Ensure corrective action is taken on all audit findings.
- Evaluates the effectiveness on the corrective action.
- Ensure unit’s activities comply with operating guidelines and policies for the organisation and function.
- Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QMS Management and coordinate the use, maintenance and calibration of testing equipment according to SOPs.
- Ensure continuous compliance with GMP standards.
- Ensure availability and optimal allocation of resources within unit.
- Participate in training, coaching and development for team members.
- Ensure that customers comply according to legislation.
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