Senior Pharmaceutical Quality Control Analyst

Placements24; Johannesburg; Presencial; ZAR 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Medical aid

Retirement fund contributions

Performance bonuses

Professional development

Descripción de la vacante

Placements24 is seeking a Senior Pharmaceutical Quality Control Analyst for our client in Johannesburg, SA. The role focuses on analytical testing of materials and products to ensure GMP/ICH compliance, with leadership responsibilities for junior analysts.

The ideal candidate will have 5+ years in pharmaceutical QC, strong instrumentation experience (HPLC/GC/dissolution), and a solid grasp of quality systems.

Formación

• Bachelor's degree or Master's in Pharmacy, Chemistry, or related field.
• Minimum of 5 years in pharmaceutical Quality Control with emphasis on analytical testing.
• Experience with analytical instrumentation such as HPLC, GC, and dissolution testing.
• Thorough understanding of GMP, ICH guidelines, and pharmacopoeial requirements.
• Method development and validation experience is highly desirable.

Responsabilidades

• Perform analytical testing of raw materials, intermediates, and finished products using HPLC, GC, UV-Vis, FTIR, and dissolution testing.
• Develop, validate, and transfer analytical methods per ICH guidelines and SOPs.
• Conduct stability studies and analyze data to determine shelf-life.
• Operate and maintain laboratory equipment with calibration/qualification.
• Review and approve analytical results ensuring regulatory compliance.
• Investigate OOS results and deviations, documenting findings and corrective actions.
• Maintain GMP-compliant laboratory records and support inspections/audits.
• Train and mentor junior QC analysts in techniques and GMP.
• Collaborate on cross-functional teams to improve QC processes.

Conocimientos

Analytical testing

Regulatory understanding

Mentoring/leadership

Documentation

Problem-solving

Communication

Educación

Bachelor's or Master's in Pharmacy/Chemistry

Herramientas

HPLC

GC

Dissolution testers

LIMS

Descripción del empleo

About the Role

Our client, a rapidly expanding pharmaceutical company, is seeking a highly skilled and meticulous Senior Pharmaceutical Quality Control Analyst to join their state-of-the-art laboratory facility. This critical role is based in Johannesburg, Gauteng, ZA, the economic hub of South Africa. You will be responsible for 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 standards. The ideal candidate will possess a deep understanding of analytical chemistry techniques, pharmaceutical quality systems, and regulatory guidelines (e.g., GMP, ICH). This position requires strong technical expertise, excellent documentation skills, and the ability to lead and mentor junior analysts. We are looking for a dedicated professional committed to upholding the highest standards of pharmaceutical quality and patient safety in a fast-paced environment.

Key Responsibilities

• Perform analytical testing of raw materials, intermediates, and finished products using various techniques such as HPLC, GC, UV-Vis, FTIR, and dissolution testing.
• Develop, validate, and transfer analytical methods according to ICH guidelines and internal SOPs.
• Conduct stability studies and analyze data to determine product shelf-life.
• Operate and maintain laboratory equipment, ensuring calibration and qualification.
• Review and approve analytical test results, ensuring accuracy and compliance with specifications.
• Investigate Out-of-Specification (OOS) results and deviations, documenting findings and implementing corrective actions.
• Maintain accurate and detailed laboratory records and ensure compliance with Good Manufacturing Practices (GMP).
• Assist in regulatory inspections and internal audits by providing necessary documentation and information.
• Train and mentor junior QC analysts on analytical techniques, equipment operation, and GMP principles.
• Participate in cross-functional teams to address quality issues and improve processes.
• Contribute to the continuous improvement of QC laboratory operations and procedures.
• Ensure compliance with all relevant pharmacopoeial standards (e.g., USP, BP, EP).

Requirements

• Bachelor's degree or Master's degree in Pharmacy, Chemistry, or a related scientific discipline.
• Minimum of 5 years of relevant experience in pharmaceutical Quality Control, with a strong focus on analytical testing.
• Proven experience with analytical instrumentation such as HPLC, GC, dissolution testers, etc.
• Thorough understanding of pharmaceutical GMP, ICH guidelines, and pharmacopoeial requirements.
• Experience in method development and validation is highly desirable.
• Excellent documentation, problem-solving, and critical thinking skills.
• Strong ability to interpret complex analytical data and regulatory requirements.
• Good interpersonal and communication skills, with the ability to work effectively in a team.
• Proficiency in laboratory information management systems (LIMS) is a plus.
• Must be legally authorized to work in South Africa.

Benefits

• Our client offers a competitive salary, comprehensive medical aid, retirement fund contributions, and potential performance bonuses.
• Opportunities for professional development, including further training and conference attendance, are provided.
• The company fosters a collaborative and quality-driven work culture.
• This role is based in Johannesburg, Gauteng, ZA, offering a dynamic urban work environment.
• The company prioritizes employee well-being and offers a supportive atmosphere.