Responsible Pharmacist
3 months ago
**Roles & Responsibilities**
- Operationally be involved with all aspects of the distribution processes and quality issues of the total company''s Warehouse organization.
- Overall responsibility to ensure that ALL operations at The company are conducted according to the requirements of The Medicines and Related Substances Act (Act 101 of 1965),
as amended, and The Pharmacy Act (Act 53 of 1974), as amended, as well as in accordance with the requirements of any other related legislation including Medical Device Regulation (2016) and ISO standards applied i.e., ISO 13485.
- Act as a Responsible Pharmacist for the company including the warehouse and the applicant.
- The Responsible Pharmacist shall be responsible to The Pharmacy Council for any act performed by or
on behalf of the company.
- Ensure that there is compliance with good pharmacy practice as published by the Pharmacy Council.
Inform management of any non-compliance issues. Not carry out any instruction/order of management which may contravene legislation.
- Establish, implement, and oversee all quality and GDP and GMP issues. Responsible for the Quality Management System (QMS) to cover the expanse of compliance required by the business scope of activity i.e., GDP, GMP, GVP, Medical Devices and approvals.
- Responsible for the control of Quarantine goods
- Responsible for QA release of the products to the market as per relevant SOP and GMP
- Ensure self-inspections as well as external audits (including international audits) are carried out.
Take corrective measures in respect of deficiencies about inspection reports.
- Be responsible for the control (initiation, reviewing, updating, issuing, superseding) of all documentation,
i.e., Standard operating procedures, Technical Agreements, Master manufacturing & packaging, raw material and packaging material specifications, Site Master File, Quality Manual etc.
- Authorize all changes and deviations as per SOP.
- Responsible for the Quality Management Review
- Responsible for the Quality Risk Assessment
- Act as a Pharmacovigilance Officer for the company and submit reports to the authority as per
legislation
- Ensure that all product complaints are investigated timeously as per SOP.
- Ensure that all staff are trained in terms of the legal aspects of sale of pharmaceutical products.
- Review all promotional and advertising material in terms of the requirements of the SAHPRA.
- Maintain records of all approved promotional material, printed packaging material
- Oversee the recall or withdrawal of any product.
- Ensure that returned goods are assessed according to the SOP.
- Ensure regular safe destruction of rejected, returned, expired, soiled, damaged goods.
- Ensure that retention samples and batch specific documentation are kept as per SOP.
- Communicate all regulatory information to relevant company personnel timeously and in good faith.
- Perform any act pertaining to a pharmacist that may be required.
- Ensure regular updating of knowledge as regards legal and regulatory aspects - including attending
training as may be necessary.
- Ensure that quality documents, such as SOPs, quality manual, master documents are regularly revised updated and authorized.
- Ensure that products are transported and stored under required conditions.
- Ensure correct and effective record keeping of the purchase, possession, storage, safekeeping, and return of medicines and medical devices.
- To establish corrective measures in respect of deficiencies about inspection reports of council or in terms of the Medicine Act
- Perform Annual Product Review as GDP/GMP Guidelines
- Co-ordinate the registration of new medicines with the authority
- Responsible for the co-ordination and management of review, updating, compilation and submission of
CTD dossiers to the SAHPRA
- Liaise with international suppliers (manufacturers) making sure that they continue to supply the company with products of good quality.
- Monitor, collect and interpret regulatory issues and trends that will impact the company’s products, policies, and procedures.
- Participate and collaborate with relevant Health Professional Associates and Societies to ensure product is registered in that territory before it can be sent to the customer.
- Participate with the company in ensuring compliance and resolve non-compliance in consultation with
them
- Review and approve all SOPs for regulatory compliance.
**MEDICAL DEVICE REGULATIONS**:
- Up-keep of Medical Device License.
- Understand and implement Medical Device guidelines in the local subsidiary.
- Maintaining technical files to be in-line with SAHPRA requirements.
- Up-date of Radiation Control license for electro-medical devices (injectors)
- Establishes and maintains a materiovigilance system.
- Manages product quality complaints.
- Ensuring Technical agreements with all suppliers of Medical Devices are in place.
- Ensuring all licenses for Medical Devices are maintained.
- Establishing system for e
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