Senior Pharma QC Manager – GMP Leader

Profile Data; South Africa; Sur place; ZAR 1 000 000 - 1 500 000; Plein temps

Résumé du poste

Profile Data in East London, Eastern Cape, seeks an experienced Pharmaceutical Quality Control Manager to lead the QC department, ensuring products meet GMP and regulatory standards.

You will manage a team of QC analysts, oversee method development/validation, equipment calibration, CAPAs, and liaise with Production, QA, and R&D to uphold product quality and patient safety.

This leadership role offers significant impact in a reputable pharmaceutical manufacturer with a strong compliance culture.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Analytical Chemistry, or related life science.
• Minimum 7 years in pharmaceutical Quality Control with at least 3 years in supervision/management.
• Extensive GMP knowledge and regulatory understanding.
• Experience with analytical techniques (HPLC, GC, UV-Vis, Karl Fischer).
• Experience in method development, validation, and transfer.
• Strong leadership and communication skills.
• Proficiency in LIMS and standard office software.

Responsabilités

• Lead, manage, and mentor the QC laboratory team.
• Oversee testing of raw materials, in-process samples, and finished products.
• Develop, validate, and transfer analytical methods for new/existing products.
• Ensure GMP compliance and regulatory guidelines (SAHPRA).
• Manage laboratory equipment calibration, maintenance, and qualification.
• Review and approve QC testing records, COAs, and deviation reports.
• Investigate OOS results and implement CAPAs.
• Liaise with Production, QA, and R&D to resolve issues.
• Manage budgets, inventory, and vendor relationships.
• Stay updated on analytical techniques and regulatory requirements.

Connaissances

Leadership

Problem solving

Decision making

Communication

Team management

Analytical thinking

Regulatory knowledge

Interpersonal skills

Quality culture

Formation

Bachelor's or Master's in Pharmacy/ Chemistry/ Analytical Chemistry

Outils

LIMS

Description du poste

Profile Data in East London, Eastern Cape, seeks an experienced Pharmaceutical Quality Control Manager to lead the QC department, ensuring products meet GMP and regulatory standards.

You will manage a team of QC analysts, oversee method development/validation, equipment calibration, CAPAs, and liaise with Production, QA, and R&D to uphold product quality and patient safety.

This leadership role offers significant impact in a reputable pharmaceutical manufacturer with a strong compliance culture.