QA/regulatory Pharmacist

**Innovata Pharmaceuticals**, which is part of the Avacare Health group is looking for a **QA/Regulatory Pharmacist** to join our team. This position is based in **Ormonde, Johannesburg.**

Avacare Health is an integrated healthcare group operating across 3 continents with presence in 22 countries, bringing affordable healthcare to the people through the distribution and supply of pharmaceuticals, medical consumables, consumer health and medical equipment.

A proudly South African company, Innovata is a level 1 BBBEE company that manufactures a range of carefully selected essential medicines covering all major therapeutic classes.

Since our inception in 2000, Innovata has established a noteworthy relationship with the Public Health Sector where we hold numerous national tenders. Not only are we committed to delivering cost-effective products timeously; our team remains committed to forging long-term relationships with customers, business partners, suppliers and employees alike.

Driven by our mission to be the benchmark for excellence in healthcare, the credibility we have attained in the Public Health Sector and the backing of our parent company, the Avacare Health Group, Innovata is well poised and eager to extend our footprint into the South African Private Health sector.

**Job Overview**:
**Purpose of the job**:
The Regulatory Pharmacist manages regulatory activities in connection to submissions of new products, Life Cycle Management, and quality assurance for approved products.

**Key Responsibilities**:
Dossiers:

- Ensure that all allocated product dossiers are of an acceptable standard, and timeously updated.
- To evaluate and compile new product dossiers for SA and for the international markets.
- To generate reports on evaluation of dossiers.
- To follow up on outstanding information required to complete dossier updating and submission of allocated dossiers.

Regulatory Management:

- Ensure that all regulatory related documentation for products allocated is correct and readily available.
- Update and review the regulatory processes in accordance with company requirements and maintain same.
- To comply with the Pharmacy Act, Medicines and Related Substances Control Act as well as the Food, Disinfectants and Cosmetics Act in respect of the company’s products allocated.
- Liaise directly with the SAHPRA and/or other regulatory authorities on regulatory matters and in respect of following up on regulatory approvals. (The RP authorizes the RA Pharmacist to communicate with the SAHPRA on his/her behalf on regulatory matters).
- To communicate all regulatory approvals to the Manager and/or relevant departments or third parties.
- To assume all pharmacovigilance activities delegated by the LPPV.
- To ensure that all training allocated for you is completed and documented.

Art Work:

- Ensure that all artwork/printed packing materials for allocated products comply with the current legislation.

Quality:

- To assist with Process and Analytical Validations of products, site validation and Quality risk management.
- To release finished products manufactured for Innovata to the market for sale.
- To uphold the Innovata Quality System by performing quality assurance functions as required to fulfil your job description.
- To assist in Self-Inspection and perform Third Party Vendor Audits.
- Ensure PQR’s are performed.

Admin & Reports:

- To submit monthly reports on work performed.
- To accept duties delegated by the responsible pharmacist when required.

**Desired skills, experience and qualifications**:
Minimum 2 - 4 years’ experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility.

BPharm Degree

Excellent report writing & communication skills.

Problem solving & analysis skills.

Results oriented and takes initiative.

**Duration**: Permanent

**Closing date for Application**:13 November 2024

**Location**:Ormonde, Johannesburg

**Innovata Pharmaceuticals (Pty) Ltd**

**_ Avacare Health Group (Avacare) and other subsidiary or affiliated companies of Avacare are committed to protecting your privacy. Avacare is an equal opportunity organization that prides itself on its diverse teams across the globe._