Quality Control Manager - Pharmaceutical Manufacturing

Placements24

Durban

Hybrid

ZAR 900,000 - 1,300,000

Full time

6 days ago
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Benefits offered by this job

Hybrid work arrangement
Competitive salary
Medical and retirement benefits
Professional development opportunities

Job summary

Placements24 in Durban is seeking an experienced Quality Control Manager to lead the QC laboratory and ensure products meet strict quality standards in a highly regulated pharma market. The role oversees testing procedures, regulatory compliance, and a team of analysts and technicians.

The ideal candidate has 8+ years in QA/QC in pharma, with at least 3 in management, and strong GMP/ICH/FDA experience, plus proficiency with LIMS and analytical methods development.

Qualifications

  • Bachelor's or Master's degree in Pharmacy, Chemistry, or related life science field.
  • Minimum of 8 years in Quality Control within pharma, with at least 3 in a leadership role.
  • Extensive GMP, regulatory guidelines (ICH, FDA, SAHPRA), and QMS knowledge.
  • Proven experience in analytical method development and validation.
  • Strong leadership, team management and interpersonal skills.
  • Excellent analytical, problem-solving and decision-making abilities.
  • Proficiency in LIMS and data analysis tools.
  • Deep understanding of pharmaceutical manufacturing processes.
  • Excellent written and verbal communication skills.
  • Ability to work effectively in a fast-paced, highly regulated environment.

Responsibilities

  • Develop, implement, and maintain the Quality Control system in line with GMP/ICH/FDA/SAHPRA standards.
  • Oversee QC laboratory operations including raw material testing, in-process testing, and finished product release.
  • Mentor and manage a team of QC analysts and technicians.
  • Develop and validate analytical methods for testing raw materials, intermediates, and finished products.
  • Ensure testing follows SOPs and timelines.
  • Review and approve analytical data, batch records, and COAs.
  • Investigate OOS results and deviations; implement CAPAs.
  • Stay updated on regulatory requirements and industry best practices.
  • Manage external audits and inspections by regulators and customers.
  • Contribute to continuous improvement of quality systems and processes.
  • Maintain and calibrate laboratory equipment.

Skills

QC management
GMP/ICH knowledge
Lab leadership
Method development
Data analysis
LIMS proficiency

Education

Pharmacy or Chemistry degree
Masters in Life Sciences

Tools

HPLC
GC
LC-MS
UV-Vis

Job description

About the Role

Our client, a leading pharmaceutical manufacturer based in Durban , is seeking an experienced and meticulous Quality Control Manager. This senior role is responsible for ensuring that all manufactured pharmaceutical products meet the highest standards of quality, safety, and efficacy. The successful candidate will oversee the quality control laboratory, manage testing procedures, ensure regulatory compliance, and lead the QC team. This is a pivotal position within our client's operations, contributing directly to the integrity and reputation of their products in the highly regulated pharmaceutical market of KwaZulu-Natal .

Key Responsibilities
  • Develop, implement, and maintain the company's Quality Control system in compliance with regulatory standards (e.g., GMP, FDA, SAHPRA).
  • Oversee all aspects of the Quality Control laboratory operations, including raw material testing, in-process testing, and finished product release.
  • Manage and mentor a team of Quality Control analysts and technicians.
  • Develop and validate analytical methods for testing raw materials, intermediates, and finished products.
  • Ensure that all testing is performed according to approved Standard Operating Procedures (SOPs) and within established timelines.
  • Review and approve analytical data, batch records, and Certificates of Analysis (CoAs).
  • Investigate out-of-specification (OOS) results and deviations, implementing corrective and preventative actions (CAPAs).
  • Stay updated on current regulatory requirements and industry best practices.
  • Manage external audits and inspections by regulatory authorities and customers.
  • Contribute to the continuous improvement of quality systems and processes.
  • Maintain and calibrate laboratory equipment.
Requirements
  • Bachelor's or Master's degree in Pharmacy, Chemistry, or a related life science field.
  • Minimum of 8 years of experience in Quality Control within the pharmaceutical industry, with at least 3 years in a management role.
  • Extensive knowledge of GMP, regulatory guidelines (ICH, FDA, SAHPRA), and quality management systems.
  • Proven experience in analytical method development and validation.
  • Strong leadership, team management, and interpersonal skills.
  • Excellent analytical, problem-solving, and decision-making abilities.
  • Proficiency in laboratory information management systems (LIMS) and data analysis tools.
  • Strong understanding of pharmaceutical manufacturing processes.
  • Excellent written and verbal communication skills.
  • Ability to work effectively in a fast-paced, highly regulated environment.
Benefits
  • Our client offers a highly competitive salary, performance bonuses, and comprehensive medical and retirement benefits.
  • Opportunities for professional growth and development, including participation in industry conferences and advanced training programs, are available.
  • This position offers a hybrid work arrangement, allowing for flexibility.
  • The role is based in our client's modern facility in Durban , providing a challenging and rewarding career path.
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