Senior Pharma QC Manager – Hybrid, GMP & Compliance

Placements24

Durban

Híbrido

ZAR 900.000 - 1.300.000

Jornada completa

Hace 6 días
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Ventajas ofrecidas por este puesto de trabajo

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

Descripción de la vacante

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.

Formación

  • 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.

Responsabilidades

  • 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.

Conocimientos

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

Educación

Pharmacy or Chemistry degree
Masters in Life Sciences

Herramientas

HPLC
GC
LC-MS
UV-Vis

Descripción del empleo

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.

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