Senior Pharmaceutical Quality Control Analyst

Placements24

Paarl

On-site

ZAR 480,000 - 720,000

Full time

39 hours ago
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Benefits offered by this job

Medical aid
Retirement fund
Life assurance
Professional development

Job summary

Placements24 is seeking a Senior Pharmaceutical Quality Control Analyst for a respected Paarl-based pharmaceutical manufacturer. The role involves extensive analytical testing of raw materials, in-process samples, and finished products to ensure GMP compliance and product safety.

You will develop and validate analytical methods, operate and maintain lab instruments, and contribute to audits and regulatory inspections. Strong GMP knowledge and attention to detail are essential for success.

Qualifications

  • Bachelor's degree in a scientific discipline and 5+ years of QC experience in pharma.
  • Proven proficiency with analytical instruments and GMP regulatory requirements.
  • Experience with method development and validation is desirable.
  • Strong attention to detail and documentation skills.
  • Ability to interpret pharmacopoeial methods and support audits.

Responsibilities

  • Perform routine and non-routine analytical testing on raw materials, intermediates, and finished products.
  • Develop, validate, and transfer analytical methods per ICH guidelines and regulatory requirements.
  • Operate, maintain, and calibrate laboratory equipment for accuracy and compliance.
  • Analyze results, prepare CoAs, and document all activities in GMP-compliant records.
  • Investigate OOS, deviations, and unexpected results; participate in root-cause analysis.
  • Review and approve analytical data generated by junior analysts.
  • Maintain laboratory inventory and consumables; support internal audits.
  • Stay updated with USP/BP standards and regulatory guidelines.
  • Collaborate with QA, Production, and R&D to ensure quality across products.

Skills

GMP principles
Analytical method development
Attention to detail
Communication skills

Education

Bachelor's degree in Chemistry, Pharmacy, Biochemistry, or related field

Tools

HPLC
GC
UV-Vis
IR
Titration

Job description

About the Role

Our client, a respected pharmaceutical manufacturer based in Paarl, Western Cape , is seeking a highly skilled and meticulous Senior Pharmaceutical Quality Control Analyst to join their dedicated laboratory team. This crucial role involves performing a wide range of analytical tests on raw materials, in-process samples, and finished pharmaceutical products to ensure they meet stringent quality and regulatory specifications. The ideal candidate will possess extensive experience with various analytical instruments and methodologies, a strong understanding of GMP principles, and a keen eye for detail. You will play a vital part in safeguarding the quality and safety of our client's pharmaceutical products. This is an excellent opportunity to contribute your expertise within a well-established pharmaceutical company located in the scenic Paarl, Western Cape region, known for its commitment to excellence in healthcare. We are dedicated to producing high-quality medicines.

Key Responsibilities
  • Perform routine and non-routine analytical testing on raw materials, intermediates, and finished products using various techniques (e.g., HPLC, GC, UV-Vis, IR, Titration).
  • Develop, validate, and transfer analytical methods in accordance with ICH guidelines and regulatory requirements.
  • Operate, maintain, and calibrate laboratory equipment to ensure accuracy and compliance.
  • Analyze test results, prepare Certificates of Analysis (CoAs), and document all laboratory activities accurately in compliance with GMP.
  • Investigate out-of-specification (OOS) results, deviations, and unexpected results, participating in root cause analysis.
  • Review and approve analytical data generated by junior analysts.
  • Assist in the maintenance of laboratory inventory and consumables.
  • Contribute to internal audits and regulatory inspections related to QC laboratory operations.
  • Stay up-to-date with current pharmacopoeial standards (e.g., USP, BP) and relevant regulatory guidelines.
  • Collaborate effectively with other departments, including Quality Assurance, Production, and R&D.
Requirements
  • Bachelor's degree in Chemistry, Pharmacy, Biochemistry, or a related scientific discipline.
  • A minimum of 5 years of relevant experience as a Quality Control Analyst in the pharmaceutical industry.
  • Proven proficiency in operating and troubleshooting common analytical instruments (HPLC, GC are essential).
  • Strong understanding of GMP principles and regulatory requirements for pharmaceutical quality control.
  • Experience with method development and validation is highly desirable.
  • Excellent attention to detail, accuracy, and organizational skills.
  • Ability to interpret and apply pharmacopoeial methods and regulatory guidelines.
  • Strong problem-solving skills and the ability to work independently and as part of a team.
  • Good written and verbal communication skills.
  • Proficiency in laboratory documentation and data management.
Benefits

Our client offers a competitive salary and benefits package, reflecting the importance of this role. This includes comprehensive medical aid, a retirement fund, and life assurance. Opportunities for professional development and training are provided to ensure continuous skill enhancement. The company values its employees and fosters a collaborative and supportive work environment in Paarl, Western Cape . You will be part of a team committed to upholding the highest standards of pharmaceutical quality and contributing to the availability of safe and effective medicines.

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