Quality Assurance Pharmacist

1 month ago

Midrand, South Africa Neoc_People Full time

PRINCIPLE DUTIES

1. QUALITY ASSURANCE:

- All for the Companies various departmental SOPs reviewed, revised and 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 approved suppliers 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 adequate pest control program is in place.
- Approval of specification sheets for release.
- Ensure Technical Quality Agreements exists between the company and 3rd party contractors/service providers regarding responsibilities.
- Implement Stability Master Plan.

2. COMPLAINTS
- To ensure that all product quality complaints are identified, investigated and dealt with correctly.

3. RECALLS
- To ensure that all batches of medicine distributed are batch traceable in the event of a recall and that all invoices carry batch numbers.

4. RETURNED / REJECTED GOODS
- To ensure that goods returned are handled in a procedurally correct manner, reason for returns determined and any further actions followed through and recorded.
- To 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.

5. GMP/GWP/GHP
- To ensure that inspection audits are performed on all third-party contractors whereby it is established that:

- All manufacturing operations are carried out in accordance with approved, written GMP and manufacturing procedures.
- The products as manufactured meet the specifications of the registration dossier and approved specifications.
- That the specified quality is maintained during storage and transport.
- That a contract packer has adequate packaging facilities, and that written systems are adhered to until delivery of the final packaged product for release for distribution.
- To ensure that all logs are completed by the distribution/warehousing facility e.g. temperature control, cleaning, maintenance etc.
- To ensure that disposal or destruction of medicines is correctly performed under proper control so as not to be a health hazard.
- To ensure that an adequate pest control program is in place at the distribution facility, using acceptable food grade bait, and to ensure that precautions are taken to ensure that product contamination does not occur.
- To ensure that self-inspection / internal audits are performed, and any deviations followed up.
- To ensure all external service providers are audited as specified in the relevant procedure.
- To ensure that 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.
- To release batches to the market according to correct procedure.
- To check all relevant documentation in order to formally release final packed product for distribution where applicable.
- To ensure GMP training is provided to all employees on an ongoing basis.

SECONDARY DUTIES

1. TRAINING
- Monitor that all employees in all the Departments are fully trained to implement and maintain GxP and on all the approved SOP's, applicable to the different departments.

KNOWLEDGE REQUIRED
- B. Pharm degree.
- Registered with the South African Pharmacy Council.
- Good computer literacy.
- Knowledge of cGxP 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 behaviour.
- 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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