Quality Assurance Pharmacist

Found in: Whatjobs ZA C2 - 4 days ago

Pinelands, South Africa Neoc_People Full time
PRINCIPLE DUTIES
1. 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

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, the 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 by 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 the correct procedure.
  • To check all relevant documentation to formally release the 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 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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