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Senior QA Pharmacist 

Job Purpose:

• Ensure adherence to the Bayer Quality System, through SOP’s, Directives, etc.
• 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 Task and Responsibilities:

• Ensure compliance with quality requirements on release of medicine, medical devices and cosmetics for sale in line with GMP/ISO13485 and Bayer Policies, Directives and SOPs, i.e.,
• Operational responsibility for the local release of Bayer products marketed in the Southern Africa region.
• Ensure that reference standards and laboratory requirements are met by continuous collaboration with the Laboratory Service Providers.
• Audit third party contractors; support the CQH in ensuring quality oversight for 3rd party business, incl. Quality Assurance Agreements (QAAs) and GMP/GDP audits.
• Support CQH in conductingSelf-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 requirements.
• Manage 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.
• Assist CQH with Medical Need Product responsibilities.
• Collaborates with CQH and Audit Program Manager to plan, coordinate, and execute audit plans, in the role as Auditor/Co-Auditor, as well as Supplier Qualification activities.
• 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.

Qualifications and Competencies:

• Minimum: B.Pharm Degree
• Minimum: 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, organising 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.

Location:

South Africa : Gauteng : Midrand  

Division:

Pharmaceuticals 

Reference Code:

845301 

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.