On behalf of our established client, a pharmaceutical company with operations in Malta and worldwide, manufacturing APIs, GRS Recruitment is seeking to recruit a Director of Quality Control. The selected candidate shall report directly to the General Manager, interact with the Head of Analytics and be part of the QC Department. This is an excellent opportunity to work with an enthusiastic, large, and dynamic team of professionals. If you have the necessary skills and experience, then GRS are looking forward to receiving your CV for this Malta based Director of Quality Control.
MAIN DUTIES AND RESPONSIBILITIES
- Lead, direct and support the QC Team in their functions
- Support the process of annual budgeting
- Perform annual reviews and assessments for all QC employees
- Elaborate, implement and control the quality system in compliance with cGMP, ICH, PIC-GMP, 21CFR regulations, global policies and cGMP-system.
- Schedule and supervise the analytical work for raw materials, excipients, intermediates, finished API, stability testing and packaging materials.
- Plan/control headcounts, budget and investments in the QC-Organization
- Establish KPIs
- Coordinate the daily work in the laboratories
- Represent quality control regarding technical questions against contract laboratories, customers, authorities etc.
- Responsible for controlling raw materials, excipients, packaging materials, intermediates and drug products in due time according to the prescriptions, Pharmacopoeias, and other external and internal guidelines
- Ensure that the procedures are followed according to Company’s policies and SOPs with respect to Out-of-Specification results, lab errors, deviations, complaints, suppliers, etc.
- Responsible for the maintenance and qualification of analytical instruments and equipment, which is used by QC
- Responsible for audits and inspections where the Analytical Services and Quality Control is concerned
- Ensure adequate documentation in the local IT systems (LIMS, etc.)
- Assists QA in handling of deviations, OOS-results and external complaints, ensures analytical support for investigations
- Keep abreast of and follows all cGMP rules as explained in the relevant Policies and SOPs, GMP Guideline (with particular reference to EU and FDA GMP Guidelines) and ICH Guidelines
- Report to the QC Supervisor any deviations from methods/SOPs/processes and cGMP rules
- Report any OOT's, OOS's and other abnormalities detected during analysis and/or review
- Holder of a degree in Chemistry, Pharmacy, or similar education
- Previous experience in the pharmaceutical industry
- Previous experience as a Director of Quality Control, QC Manager or similar positions
Due to the high volume of applications we receive at GRS Recruitment, only shortlisted candidates will be responded to.
To apply for this position, please email your CV to Giuseppe Buda, firstname.lastname@example.org
quoting the above job reference or call +356 2778 0664
for further information.