Slough | £30K/Year | Ref. VAC-12323
An experienced Quality Assurance Officer is urgently required for Japan’s leading whole pharmaceutical wholesaler to join its rapidly growing UK office.
The QA Specialist will manage quality systems, processes, and procedures to assure product safety and quality by driving business alignment to correct industry requirements and business objectives by managing quality system design, controls, and continuous improvement.
The QA Specialist will be responsible for engaging strong intradepartmental and cross- functional/organisational relationships to drive Quality System Requirements (QSRs)
Working Hours : Mon-Fri 9:00 – 17:30
Annual Leave Entitlement : 20 days + UK bank holidays
Main duties and responsibilities:
To perform regular In-process QA checks for packaging area.
To verify and ensure that all processes/procedures are validated and approved.
Primary review of batch documentation (BMR/BPR) before QP approval.
To prepare, review and update SOP’s for quality management systems as applicable.
To maintain database for quality parameters including trending, periodic review and assessment reports as applicable.
Review & update of Technical Agreements, To participate in Audits (External/Internal)
Perform & review of Change control, Incident Report Forms, Customer complaints etc.
Perform Pre & post assembly checks.
Training to new staffs on GMP, GDP. Maintaining training records.
Influencing quality system metrics such as Corrective and Preventive Action, training metrics, completion and complain resolution metrics
Respond, at the initiation of the Responsible Person, to any other special requests that may arise.
Influencing site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines
Perform any other appropriate duties at the request of the Management
Good understanding of Good Manufacturing Practice (GMP) & Good Distribution Practise (GDP).
Bachelor’s degree or equivalent
Proven experience working in a regulated pharmaceutical environment, quality control/assurance, or regulatory assurance
Proven experience in Quality Management Systems (QMS)
Analytical & problem-solving skills/root-cause analysis
Ability to effectively communicate verbally and in writing using the English Language
Experience using word processing, spreadsheet, and presentation software