Sr. Supervisor, QA

Hikma Quality

We are looking for a talented Sr. Supervisor, QA to join us. At Hikma you ll be supported by a culture of progress and belonging where people are encouraged to develop, wellbeing is prioritised and our inclusive approach values contributions from all. We re seeking candidates who embody our values: Innovative, driven to keep learning; Caring, genuinely compassionate in their work; and Collaborative, eager to solve problems together.

If you want to be part of a team that cares about impact, this is the place for you.

Key Responsibilities:

• Handle and approve deviations, investigations, and laboratory investigations (OOS, OOT, variances, incidents).
• Ensure product compliance with specifications and cGMP requirements.
• Manage product release activities, complaints, claims, and non-conforming products.
• Approve validation protocols/reports, process validation, stability protocols, APRs, and master batch records.
• Review and approve change controls.
• Perform risk assessments and review gap analysis reports.
• Lead and support internal and external audits.
• Review and approve QC equipment qualifications (IQ/OQ/PQ) and calibrations.

• Conduct QA audits, QA rounds, and in-process checks, documentation reviews, ensuring completeness and compliance.
• Control personnel, materials, equipment, and document flow to prevent contamination and mix-ups.
• Manage document lifecycle (issuance, revision, archival) and controlled copies.
• Create, update, and review SOPs, including periodic review cycles.
• Verify logbooks and oversee document destruction activities.

• Prepare and review CAPA and quarterly reports, ensuring effectiveness tracking.
• Issue and follow up on Quality Circles.
• Manage quality metrics, data tracking, and continuous improvement initiatives.
• Act as Veeva champion (enhancements, system support, and budgeting).
• Manage employee training curricula and compliance.
• Support training and manage QA team members.
• Coordinate with cross-functional teams and pharmacovigilance.