Specialist : Compliance

Bmw Group; Gauteng; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Quality Assurance professional to ensure compliance with quality standards for medicines and medical devices. The role involves overseeing product releases, managing quality issues, and collaborating with regulatory authorities. Ideal candidates will have at least 5 years of experience in Quality Assurance and be a registered pharmacist. Strong communication and analytical skills are essential for success in this role.

Qualifications

• Minimum 5 years of experience in Quality Assurance work.
• Knowledge of pharmaceutical regulations at national and regional levels.

Responsibilities

• Ensure compliance with quality standards for medicines and medical devices.
• Oversee local release of Bayer products in Southern Africa.
• Manage product complaints and quality issues.

Skills

Communication

Organizational skills

Analytical skills

Project management

Adaptability

Education

Registered Pharmacist

Job description

At Bayer, we're visionaries driven to solve the world's toughest challenges, striving for a world where 'Health for all, Hunger for none' is no longer just a dream but a reality. We do this with energy, curiosity, and dedication, learning from diverse perspectives, expanding our thinking, and redefining 'impossible'. If you're eager to build a meaningful career in a community of brilliant minds and make a real difference, Bayer is the place for you.

Job Purpose:

Ensure adherence to the Bayer Quality System through SOPs, Directives, and related procedures.

Guarantee compliance with quality requirements for the release of medicines for sale, in line with GMP and Bayer policies.

Maintain the local Bayer Quality System in accordance with global Bayer policies and SOPs.

Collaborate with Local Regulatory Affairs to ensure a continuous supply of compliant medicines.

Act as Deputy to the Country Quality Head (CQH) in their absence.

Key Tasks and Responsibilities:

• Ensure compliance with quality standards for the release of medicines, medical devices, and cosmetics, aligned with GMP/ISO and Bayer policies.
• Oversee the local release of Bayer products in the Southern Africa region.
• Work with Laboratory Service Providers to meet standards and requirements.
• Audit third-party contractors and support the CQH in quality oversight, including QAAs and GMP/GDP audits.
• Support CQH in conducting self-inspections.
• Ensure standards at warehouses, transportation, and contract manufacturing sites meet Bayer and country-specific quality requirements.
• Conduct GMP/GDP training for Bayer personnel.
• Collaborate with the Responsible Pharmacist and QA Manager/CQH on deviation management.
• Manage product complaints, counterfeits, and quality issues; participate in the Product Quality and Safety Committee.
• Build and maintain relationships with colleagues, healthcare professionals, service providers, and regulatory authorities.
• Assist CQH with Medical Need Product responsibilities.
• Coordinate audit activities and supplier qualification as part of the audit team.
• Support day-to-day operations to meet consumer health quality standards.
• Manage analytical method transfers between originator and local labs.

Qualifications and Competencies:

• Minimum 5 years of experience in Quality Assurance work.
• Registered Pharmacist.
• Excellent communication skills and fluency in English.
• Strong organizational and administrative abilities.
• Analytical skills, project management, and adaptability.
• Knowledge of pharmaceutical regulations at national and regional levels.

Location:

Division: Pharmaceuticals

Reference Code:

Bayer is an equal opportunity employer committed to diversity and inclusion, welcoming applicants regardless of race, gender, age, disability, or other lawful criteria.