RP/QA Manager

JOB SPECIFICATIONS:

• Minimum requirement: BPharm Degree
• A minimum of 3-5 years of Manufacturing and Quality experience is needed
• A minimum of 5-10 years of Management experience in Pharmaceutical, API, or medical device manufacturing facilities
• Must have 3-5 years of Management/Supervisory experience
• Must be registered with the Pharmacy Council
• Must have completed Internship & Community Service
• Must have experience in validation processes and requirements
• Must have internal and overseas vendor auditing experience
• Sound knowledge of GMP regulations (European, US, UK, WHO, PICS)
• Knowledge of other pharmaceutical and scientific standards (ICH, Pharmacopoeia, etc.)
• Knowledge and understanding of Quality Management Systems in pharmaceutical and related industries
• Must have had exposure to international pharmaceutical practices
• Knowledge of engineering systems as relates to utilities and equipment in facilities
• Sound knowledge of manufacturing products and processes
• Knowledge of packaging technology is an advantage
• Microbiological experience would be advantageous
• Product registration experience would be advantageous
• Computer proficiency in MS Office and SAP

BASIC JOB FUNCTIONS (Brief Summary)

• SAHPRA Permit Applications
• Obtaining the necessary permits for import and export of Specified Schedule 5 and Schedule Substances
• Host customer and regulatory audits on behalf of Fine Chemicals
• Technical, supply, and quality agreements are completed accurately and timeously
• Ensure annual renewal takes place with the South African Pharmacy Council (SAPC)
• Ensure that Management Review (QSMR) of the Quality System is conducted periodically
• Suitable systems exist for the management of SOPs, change control, deviations are investigated and resolved, CAPA is raised where appropriate, and review and approval of all quality-related documents
• Systems are managed to ensure compliance with standards in QSMR meetings
• Establish policies and procedures concerning acts performed and services provided in the company relating to scheduled substances
• Ensure that there is an effective system for the release/rejection of all APIs/intermediates for use outside the control of FCC
• To ensure legal compliance to all Acts, i.e. the Pharmacy Act (Act No 53 of 1974, as amended) and the Medicines and Related Substance Control Act (Act 101 of 1965, as amended)
• To carry out the duties of a Responsible Pharmacist in accordance with Regulations 28 of the Pharmacy Act
• To act responsibly in the practice of pharmacist in accordance with operational requirements of the business
• Initiate, compose, implement, and regularly update all documentation related to the Quality Unit
• Train appropriate personnel in SOPs and other relevant areas
• Administer and conduct internal audits
• Participate in the batch release process by ensuring adherence of products to GMP guidelines
• Manage and maintain the Quality Management System
• Manage and control staff and other resources as required to meet the objectives of the Quality Unit and FCC
• Adhere to and promote compliance with H&S regulations
• Conduct supplier audits and participate in vendor management processes

PERSONAL ATTRIBUTES (Brief Summary)

• Good organizational skills, proven leadership skills, and self-driven
• Exceptional attention to detail and accuracy
• Excellent report writing and document reviewing skills
• Uncompromising individual integrity and work ethic
• Exercise interpersonal skills, communication, training, and problem-solving skills to optimize team performance
• Demonstrate initiative and apply advanced concepts
• Proven leadership skills, self-driven and motivated