Senior Pharmaceutical Quality Assurance Analyst

Placements24; United States; Remote; USD 53,000 - 77,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Generous paid time off

Professional development opportunities

Retirement savings with company match

Access to R&D facilities

Inclusive culture and career growth

Job summary

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Analyst for a pivotal role in Midrand, Gauteng. You will ensure GMP-compliant QA systems across manufacturing and R&D, conduct audits, review batch records, and drive CAPA actions with a strong focus on regulatory alignment.

The role requires 5+ years in pharma QA, deep GMP/GLP knowledge, and the ability to lead cross-functional audits and continuous improvement while mentoring junior staff.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related life science discipline. A Master's degree is advantageous.
• Minimum of 5 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of GMP, GLP, and regulatory guidelines (FDA, EMA, SAHPRA).
• Proven experience in conducting internal and external audits.
• Strong understanding of pharmaceutical manufacturing processes, quality control principles, and validation methodologies.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency in data analysis and reporting, with strong attention to detail.
• Effective communication and interpersonal skills across departments.
• Experience with electronic quality management systems (eQMS) is a plus.
• Familiarity with risk management principles.

Responsibilities

• Develop, implement, and maintain QA systems and procedures per regulatory guidelines (GMP, ICH).
• Conduct internal audits and inspections of sites and processes to identify non-compliance and recommend CAPA.
• Review and approve batch records, validation protocols, and other critical documents.
• Investigate deviations, OOS results, and customer complaints, identifying root causes and CAPA.
• Collaborate with R&D, manufacturing, regulatory affairs, and supply chain to drive improvements.
• Prepare reports and present findings to senior management on quality metrics and compliance.
• Stay current with regulatory changes and best practices to keep quality systems effective.
• Participate in external regulatory audits and supplier audits.
• Mentor and guide junior QA team members.

Skills

Analytical reasoning

Problem solving

Decision making

Communication skills

Interpersonal skills

Attention to detail

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy, Chemistry, Biology or related life sciences

Master's degree advantageous

Tools

eQMS

Job description

About the Role

Our client, a leading innovator in the pharmaceutical sector, is seeking a highly motivated and experienced Senior Pharmaceutical Quality Assurance Analyst to join their dynamic team. This pivotal role is based in Midrand, Gauteng, ZA, a vibrant hub for technological advancement and scientific discovery. The successful candidate will play a crucial part in ensuring the highest standards of quality and compliance across all pharmaceutical manufacturing processes. This position offers an exceptional opportunity to contribute to a company that is at the forefront of developing life-changing medications and treatments, working within a collaborative and forward-thinking environment. We are looking for an individual with a keen eye for detail and a deep understanding of regulatory requirements to uphold our client's commitment to excellence.

Key Responsibilities

• Develop, implement, and maintain comprehensive quality assurance systems and procedures in accordance with regulatory guidelines (e.g., GMP, ICH).
• Conduct internal audits and inspections of manufacturing sites, laboratories, and operational processes to identify areas of non-compliance and recommend corrective actions.
• Review and approve batch records, validation protocols, and other critical documentation to ensure adherence to specifications and quality standards.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, identifying root causes and implementing effective CAPA (Corrective and Preventive Actions).
• Collaborate with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to address quality issues and drive continuous improvement initiatives.
• Prepare reports and present findings to senior management regarding quality metrics, audit results, and regulatory compliance status.
• Stay abreast of evolving regulatory landscapes and industry best practices, ensuring the company's quality systems remain current and effective.
• Participate in external audits by regulatory authorities and partners.
• Mentor and provide guidance to junior QA team members.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is advantageous.
• Minimum of 5 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant international regulatory guidelines (e.g., FDA, EMA, SAHPRA).
• Proven experience in conducting and leading internal and external audits.
• Strong understanding of pharmaceutical manufacturing processes, quality control principles, and validation methodologies.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency in data analysis and reporting, with strong attention to detail.
• Effective communication and interpersonal skills, with the ability to collaborate effectively across departments.
• Experience with electronic quality management systems (eQMS) is a plus.
• Familiarity with risk management principles.

Benefits

• Competitive annual salary package: .
• Comprehensive health, dental, and vision insurance.
• Generous paid time off, including vacation, sick leave, and public holidays.
• Opportunities for professional development and continuous learning through workshops, conferences, and further certifications.
• Retirement savings plan with company matching contributions.
• Access to cutting-edge research and development facilities in Midrand, Gauteng, ZA.
• A supportive and inclusive work culture that values innovation and employee well-being.
• Potential for career advancement within a growing global pharmaceutical organization.