RA/QA Manager (Pharmaceutical Company) – Johannesburg North, Gauteng 171 views

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