Quality Assurance Pharmacist
Reference: JHB000099-Sines-3
Our client is looking for a Quality Assurance Pharmacist with the responsibility to oversee all key elements of the Quality Management System (QMS) and monitor its effectiveness. The role ensures quality standards and current procedures meet regulations for GxP. The QA Pharmacist coordinates and liaises with other Departments to ensure a strong Quality Assurance culture throughout the Company, continuously improving Quality Standards and providing guidance as required. This position must assist to oversee all the quality assurance arrangements and report to senior management.
JOB SUMMARY
The Quality Assurance Pharmacist must have a deep understanding of the importance of an effective Quality Management System and has a crucial responsibility to assist in the implementation of it accordingly and to ensure it continuously meets the regulations of Good Manufacturing Practices (GMP). An effectively maintained QMS will lead to streamlined business processes as well as beneficial cost savings.
Duties & Responsibilities
PRINCIPLE DUTIES
- QUALITY ASSURANCE:
- All of the Company's various departmental SOPs reviewed, revised updated, and correctly authorised.
- Manage all QA departmental functions as listed, but not limited to:
- QA document control.
- Site Master File.
- Quality Manual and Quality Policy.
- Implement the Validation Master Plan.
- Approve and manage the approved supplier's list.
- Internal and External Audits and any deviations are followed up.
- Liaise with service providers regarding QA matters.
- Non-conformance (Deviations and OOS) documentation and investigations.
- Adverse Drug Reaction (ADR) support.
- Root Cause Analysis (RCA).
- Corrective and Preventative Actions (CAPA).
- Change Controls.
- Process validations.
- Method validations.
- Product Quality Reviews.
- Quality Management Review (QMR meetings).
- Ensure an adequate pest control program is in place.
- Approval of specification sheets for release.
- Ensure Technical Quality Agreements exist between the company and 3rd party contractors/service providers regarding responsibilities.
- Implement a Stability Master Plan.
- Experience in Medical Devices.
- COMPLAINTS:
- Ensure that all product quality complaints are identified, investigated, and dealt with correctly.
- RECALLS:
- Ensure that all batches of medicine distributed are batch traceable in the event of a recall and that all invoices carry batch numbers.
- RETURNED / REJECTED GOODS:
- Ensure that goods returned are handled in a procedurally correct manner, the reason for returns determined, and any further actions followed through and recorded.
- Ensure that goods due to be rejected are handled in a procedurally correct manner.
- Final decision to re-analyze, re-pack, or destroy any returned/rejected goods.
- GMP/GWP/GHP:
- Ensure that inspection audits are performed on all third-party contractors whereby it is established that:
- All manufacturing operations are carried out by approved, written GMP and manufacturing procedures.
- The products as manufactured meet the specifications of the registration dossier and approved specifications.
- Specified quality is maintained during storage and transport.
- Contract packer has adequate packaging facilities, and that written systems are adhered to until delivery of the final packaged product for release for distribution.
- Ensure that all logs are completed by the distribution/warehousing facility e.g. temperature control, cleaning, maintenance, etc.
- Ensure disposal or destruction of medicines is correctly performed under proper control so as not to be a health hazard.
- Ensure an adequate pest control program is in place at the distribution facility, using acceptable food-grade bait, and ensure that precautions are taken to ensure that product contamination does not occur.
- Ensure self-inspection/internal audits are performed, and any deviations followed up.
- Ensure all external service providers are audited as specified in the relevant procedure.
- Ensure all goods on arrival at the company or the various contract manufacturing facilities are placed in quarantine, sampled for testing, and retained in quarantine until formally released.
- Release batches to the market according to the correct procedure.
- Check all relevant documentation to formally release the final packed product for distribution where applicable.
- Ensure GMP training is provided to all employees on an ongoing basis.
SECONDARY DUTIES
- TRAINING:
- Monitor that all employees in all the Departments are fully trained to implement and maintain GxP and on all the approved SOPs, applicable to the different departments.
KNOWLEDGE REQUIRED
- B. Pharm degree.
- Registered with the South African Pharmacy Council.
- Good computer literacy.
- Knowledge of cGMP regulations.
- Bilingual: English and Afrikaans.
EXPERIENCE REQUIRED
- Minimum 5 Years QA experience.
- SOP and master QA document compilation/control.
- Thorough understanding of the South African Regulatory Environment.
SKILLS REQUIRED
- Strong Communication Skills.
- Ethical principles and behavior.
- Ability to work in a team.
- Extensive support.
- Deadline driven.
- Customer Focus.
- Can work well under pressure.
- Detail oriented.
- Good analytical skills.
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