QA Pharmacist - Isando at Bayer

Role purpose

• To ensure compliance to quality requirements on release of medicine for sale in line with GMP and Bayer Policies, Directives and SOPs. 
• Maintain the local Bayer Quality System, in line with Global Bayer Policies, Directives and SOP’s.
• Collaborate with Local Regulatory Affairs, to ensure continuous supply of compliant medicines to our market.
• Deputizes as Country Quality Head in the absence of the CQH

Key responsibilities and tasks

• Ensure adherence to the Bayer Quality System, through SOP’s, Directives, etc.
• Ensure compliance to quality requirements on release of medicine for sale in line with GMP and Bayer Policies, Directives and SOPs, i.e., Operational responsibility for the local release of Bayer products marketed in the Southern Africa region.
• Audit third party contractors; supports the CQH in ensuring quality oversight for 3rd party business, incl. Quality Assurance Agreements (QAAs) and GMP/GDP audits.
• Support CQH in conducting Self-Inspections.
• Ensures appropriate standards & processes at local warehouse, transportation, and contract manufacturing (incl. repackaging, relabeling activities, QC Laboratories) by evaluating quality systems that our suppliers, vendors and other GxP service providers follow in relation to Bayer’s requirements or the respective country quality or GMP requirements.
• Conduct GMP / GDP Training for personnel within Bayer.
• Collaborates with the Responsible Pharmacist and QA Manager/CQH in ensuring correct deviation management, according to global QMS (e.g., temperature deviations due to transportation)
• Executes local change management.
• Manages product technical complaints, counterfeits & Quality-related issues; and is part of the local Product Quality and Safety Committee of all medicines within Bayer.
• Establish and maintain effective relationships with Bayer colleagues, healthcare professionals, third party service providers and Regulatory Authorities.
• Perform CQH functions as required in the absence of CQH; acts as Deputy Country Quality Head.
• Plan, coordinate and execute audit plans, in the role as Audit Program Manager, as well as Supplier Qualification activities (Database for Qualified Suppliers).
• Carry out day to day operational functions to assist CQH with Consumer Health quality requirements.
• Caretake Analytical Method Transfer activities between originator and local testing laboratories.

Experience, Skills and Qualifications

• Minimum: Pharm Degree
• Minimum: 3 - 5 years’ experience in Quality Assurance work prior to appointment
• Registered Pharmacist
• Good communication skills and fluency in English
• Organizational and administrative skills
• Good analytical, organizing and communication skills
• Good Computer literacy
• Commercial awareness, good project management skills and an ability to adapt to changing priorities
• Knowledge of national and regional pharmaceutical regulatory requirements