Senior Pharmaceutical QA Analyst - GMP, Audits & Compliance

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

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.