Job Title: Quality Assurance Specialist
Overview:
We are seeking a skilled Quality Assurance Specialist to join our team.
Position Description:
The Quality Assurance Specialist is responsible for the operations of Site Quality metrics, leading monthly Quality Management Reviews, and providing QA systems support as required. The role also involves advisor duties on NPI requirements for material qualification from development through clinical to commercial product manufacturing.
Main Responsibilities:
* Collate Site Quality Metrics (weekly/monthly/annually) and monitor trends with actions.
* Lead the monthly Site Quality Management Review.
* Provide oversight of Supplier qualification.
* Back-room lead for all customer audits and regulatory inspections.
* Part of the internal Audit team on site.
* Manage changes for GMP compliance in accordance with change control procedure for facilities, utilities, lab, and manufacturing equipment and control system changes (where required).
* Review and approval of GMP SOPs (where required).
* Ensure that all activities are conducted to meet GMP regulations, site or corporate quality standards, and any additional regulatory requirements.
Required Skills and Qualifications:
A Bachelor's or Master's degree in Chemistry or a related scientific field is required, with a minimum of 3 years of experience in the pharmaceutical industry in a similar role. Strong initiative and capability of working both independently and collaboratively across the organization are essential.
Benefits Include:
* Excellent opportunities for career enhancement and personal development.
* Competitive base salary.
* Annual bonus linked to business results.
* Well-established further education program.
* Pension scheme.
* Private healthcare.