Senior Pharmaceutical Quality Control Analyst

Placements24; Upington; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary package

Health insurance

Job summary

Placements24 is seeking a Senior Pharmaceutical Quality Control Analyst in Upington, Northern Cape, SA. The role focuses on ensuring products meet GMP standards and regulatory requirements, with responsibilities spanning method development, data analysis, and CAPA execution.

The ideal candidate has 5+ years in QA/QC, proficiency in HPLC/GC/UV-Vis/FTIR, and experience with LIMS/ELN. Relocation to Upington is expected in a dynamic pharmaceutical environment.

Qualifications

• Bachelor’s or Master’s in Pharmacy, Chemistry, Biotechnology, or related.
• Minimum 5 years in pharmaceutical quality control/QA.
• Experience with HPLC, GC, UV-Vis, FTIR, and dissolution testing.
• Knowledge of GMP and ICH guidelines for SA industry.
• Strong data analysis and CAPA/OOS experience.
• Experience with LIMS/ELN systems.

Responsibilities

• Conduct QC testing on raw materials, in-process samples and finished products.
• Develop, validate, and implement analytical methods per GMP/ICH.
• Analyze data, prepare reports, and advise on release decisions.
• Investigate OOS results and deviations; implement CAPA.
• Maintain equipment, calibration, and safety protocols.
• Collaborate with cross-functional teams to support product lifecycle.

Skills

HPLC

GC

UV-Vis

FTIR

Dissolution

LIMS

ELN

CAPA

OOS investigations

Data analysis

Leadership

Education

Bachelor’s or Master’s in Pharmacy/Chemistry/Biotechnology

Tools

LIMS

ELN

Job description

About the Role

Our client, a leading entity in the pharmaceutical sector, is seeking to appoint a highly skilled and dedicated Senior Pharmaceutical Quality Control Analyst to join their dynamic team. This pivotal role is based in the **vibrant city of Upington, Northern Cape**. The successful candidate will play a crucial part in ensuring that all manufactured pharmaceutical products meet stringent quality standards and regulatory requirements. This is an excellent opportunity for a meticulous professional looking to advance their career in a challenging yet rewarding environment within the **South African pharmaceutical industry**. We are committed to fostering a culture of excellence and innovation, and this position is integral to our ongoing success and commitment to public health.

Key Responsibilities

• Conducting comprehensive quality control testing on raw materials, in-process samples, and finished pharmaceutical products using advanced analytical techniques and instrumentation.
• Developing, validating, and implementing new analytical methods in accordance with regulatory guidelines (e.g., GMP, ICH).
• Analyzing and interpreting test data, preparing detailed reports, and making recommendations for product release or rejection.
• Investigating out-of-specification (OOS) results and deviations, identifying root causes, and implementing corrective and preventive actions (CAPA).
• Maintaining laboratory equipment, ensuring proper calibration, and adhering to safety protocols.
• Collaborating with cross-functional teams, including Production, Regulatory Affairs, and Research & Development, to address quality issues and support product lifecycle management.
• Mentoring and training junior laboratory staff on analytical techniques and quality procedures.
• Staying abreast of the latest scientific advancements and regulatory changes impacting pharmaceutical quality control.
• Ensuring compliance with all relevant Good Manufacturing Practices (GMP) and other applicable regulatory standards.

Requirements

• A Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.
• A minimum of 5 years of experience in pharmaceutical quality control or quality assurance.
• Proven expertise in analytical techniques such as HPLC, GC, UV-Vis spectroscopy, FTIR, and dissolution testing.
• Thorough understanding of GMP, ICH guidelines, and other relevant regulatory requirements for the **pharmaceutical industry in South Africa**.
• Excellent data analysis and interpretation skills, with a keen eye for detail.
• Strong problem-solving abilities and experience with OOS investigations and CAPA implementation.
• Proficiency in laboratory information management systems (LIMS) and electronic lab notebooks (ELN).
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Demonstrated leadership potential and experience in mentoring junior team members.
• Residency or willingness to relocate to **Upington, Northern Cape**.

Benefits

• Competitive annual salary package commensurate with experience.
• Comprehensive health insurance coverage, including medical and dental.
• Opportunities for professional development, further training, and career advancement within the company.
• Generous paid time off and company holidays.
• A supportive and collaborative work environment focused on scientific excellence.
• Contribution to the development and manufacturing of life-saving medications.