RA/QA Manager (Pharmaceutical Company) – Johannesburg North, Gauteng 166 views

Job Overview

Requirements:

 

  • Diploma or Degree in BPharm or Healthcare
  • At least 5 years in pharmaceutical (RA and QA) experience is required
  • Experience in Pharmacovigilance

 

Knowledge, Skills and Attributes:

  • Problem solving; analytical skills; service orientation; decision making skills; interpersonal skills; report writing skills; attention to detail; initiative; confidentiality; customer focused; logical thinking; information seeking; sense of urgency; computer literacy
  • Work independently as well as in a team, possess strong written and verbal communication skills, and have sound work ethics
  • Certificate or higher in health sciences, biomedical technology, business administration, or equivalent qualification
  • Experience in Quality Assurance and/or Regulatory Affairs in a pharmaceutical environment would be advantageous

 

The main purpose of this position:

 

Quality Assurance function – To assist in all necessary functions to ensure company compliance with sound Quality Assurance principles, Good Manufacturing Practice and regulatory requirements relating to the warehousing/distribution of medicines in

South Africa, including the product complaint reporting process, product release, internal and external audits and relevant training

 

Duties & Responsibilities:

 

Regulatory Affairs Function

  • To assist in product lifecycle management
  • Day-to-day RA tasks
  • Compilation of minor variation responses
  • Updating of PI and PIL leaflets to follow latest SAHPRA guidelines
  • Liaising with various departments and regulatory bodies
  • Administrative activities
  • Samples/Courier services – local & international
  • Co-ordination of intellectual hard copy material for off-site storage
  • Co-ordination of on-site shredding services of confidential documents

 

General

Ensure compliance to:

 

  • SAHPRA for compliance with the requirements of the Medicines and Related
  • Substances Act 101 of 1965, and the
  • Pharmacy Council for compliance with the requirements of the Pharmacy Act,
  • 53 of 1974
  • Aid and support Health Safety & Environmental compliance
  • All activities will be under the supervision of a pharmacist

 

Quality Assurance Function

  • Release of imported and locally manufactured products
  • Review batch manufacturing, packaging, and laboratory documentation to ensure that production controls, production conditions and results of testing comply with the procedure and finished product specification
  • Ensure that batch traceability is maintained for all products (recall procedure)
  • Request and review annual product quality reviews
  • Trending of local data for all products
  • Management of reference samples as well as retention samples
  • Ensure that additional sampling, inspection, tests, and checks are carried out or initiated, as appropriate
  • Assist in the decision-making of rejected goods, materials, and components.
  • Managing & maintaining the Quality Management System
  • Setting up and facilitating management review meetings
  • Handling and actioning non-conformances
  • Implementing CAPA’s (Corrective Actions & Preventative Action)
  • Identify and implement improvement opportunities
  • Review, update, and maintain master documents, standard operating procedures, and release and batch manufacturing documents
  • Responsible for the internal and external audit plan, inspections, reports, and reviews according to the SOP requirements
  • Assist and manage statutory inspections from SAHPRA, SAPC, and DOH

Review and update the Site Master File as well as the Quality Manual

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Contact Us

Unit 3 Sunningdale Suites
12 Wild Wood Close
Sunningdale
Cape Town
Send an email
+27 21 554 5309 / +27 21 200 6629