Lead Pharmaceutical Quality Control Analyst

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

Benefits offered by this job

Medical aid

Retirement fund

Paid time off

Professional development

Training & seminars

Career progression

Job summary

Placements24 in Upington, Northern Cape, seeks a Lead Pharmaceutical Quality Control Analyst to oversee the QC laboratory operations, ensuring all testing meets GMP and pharmacopoeial standards. You will develop and validate analytical methods for raw materials, in-process and finished products, review data and batch records, train analysts, and liaise with regulators.

A minimum 6 years in QC with 2 in a lead role is required.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, or related field.
• A minimum of 6 years in pharmaceutical quality control, with at least 2 years in a lead or supervisory role.
• Extensive knowledge of analytical techniques such as HPLC, GC, UV-Vis, IR spectroscopy, and wet chemistry.
• Thorough understanding of GMP, ICH guidelines, and SA regulations.
• Proven ability to investigate OOS results and implement effective CAPAs.
• Experience with LIMS is preferred.
• Excellent leadership, communication, and interpersonal skills.
• Strong problem-solving abilities and attention to detail.
• Ability to work under pressure and meet deadlines.
• Proficiency in data analysis and report writing.

Responsibilities

• Lead and manage the day-to-day operations of the Quality Control laboratory in Upington.
• Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished products.
• Ensure all QC testing is performed in GMP and relevant pharmacopoeial standards.
• Review and approve analytical data, batch records, and validation reports.
• Investigate out-of-specification (OOS) results and implement CAPAs.
• Manage the qualification and calibration of laboratory equipment.
• Train and mentor QC analysts, ensuring high technical proficiency and adherence to procedures.
• Liaise with regulatory authorities during inspections and audits.
• Contribute to continuous improvement of quality systems and processes.
• Maintain accurate and organized laboratory records, ensuring data integrity.

Skills

Leadership

Quality systems

GMP compliance

CAPA management

Data analysis

Report writing

Training & mentoring

Communication

Problem solving

Regulatory liaison

Education

Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology or related field

Tools

HPLC

GC

UV-Vis

IR spectroscopy

Wet chemistry

LIMS

Job description

About the Role

Our client, a distinguished name in the pharmaceutical industry, is seeking a highly skilled and experienced Lead Pharmaceutical Quality Control Analyst to be based in **Upington, Northern Cape**. This pivotal role involves overseeing all aspects of quality control testing and compliance within our client's manufacturing operations. The ideal candidate will possess a deep understanding of pharmaceutical quality systems and regulatory requirements. They will be responsible for ensuring that all products meet stringent quality standards before release, thereby safeguarding public health and upholding the company's reputation. This position is critical for maintaining the integrity and excellence of our client's pharmaceutical offerings. We are looking for a meticulous and driven professional who can lead a team and contribute to continuous quality improvement initiatives.

Key Responsibilities

• Lead and manage the day-to-day operations of the Quality Control laboratory in **Upington**.
• Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished products.
• Ensure all QC testing is performed in compliance with Good Manufacturing Practices (GMP) and relevant pharmacopoeial standards.
• Review and approve analytical data, batch records, and validation reports.
• Investigate out-of-specification (OOS) results and implement corrective and preventive actions (CAPAs).
• Manage the qualification and calibration of laboratory equipment.
• Train and mentor QC analysts, ensuring a high level of technical proficiency and adherence to procedures.
• Liaise with regulatory authorities during inspections and audits.
• Contribute to the continuous improvement of quality systems and processes.
• Maintain accurate and organized laboratory records, ensuring data integrity.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, or a related scientific field.
• A minimum of 6 years of experience in pharmaceutical quality control, with at least 2 years in a lead or supervisory role.
• Extensive knowledge of analytical techniques such as HPLC, GC, UV-Vis, IR spectroscopy, and wet chemistry.
• Thorough understanding of GMP, ICH guidelines, and South African pharmaceutical regulations.
• Proven ability to investigate OOS results and implement effective CAPAs.
• Experience with laboratory information management systems (LIMS) is preferred.
• Excellent leadership, communication, and interpersonal skills.
• Strong problem-solving abilities and attention to detail.
• Ability to work under pressure and meet demanding deadlines.
• Proficiency in data analysis and report writing.

Benefits

• Our client provides a competitive salary commensurate with experience, along with performance incentives.
• A comprehensive benefits package includes medical aid, retirement fund contributions, and paid time off.
• Professional development opportunities, including training and attendance at industry seminars, are encouraged.
• The **pharmaceutical** company fosters a supportive and growth-oriented work environment.
• Access to advanced laboratory equipment and a commitment to employee well-being are core values.
• This role offers significant potential for career progression within the quality assurance and control domain.