Job Title:
Quality Systems Specialist
Description
We are currently recruiting for a leading pharmaceutical organization. This is an excellent opportunity for professionals looking to join the industry.
* Complete sub-system responsibilities per site system ownership list.
* Drive quality performance metrics and continuous improvement within owned systems.
* Serve as quality SME for validation across drug substance and drug product operations.
* Participate in PVC, WVC, CVG, and EQVC committees.
* Approve validation documentation and support capital projects.
* Maintain validated state post-change; develop summary reports and quality plans.
* Principal quality contact for all site change requests affecting processing.
* Conduct full lifecycle reviews for change controls and material strategy assessments.
* Provide QA oversight for laboratory systems, documentation, and incidents.
* Approve stability reports and support OOS investigations.
* Act as the microbiology QA point of contact for water, utilities, environment, and product-related issues.
* Own and maintain the site master file, validation master plan, and key procedures.
* Oversee annual review and quality agreement systems.
* Approve user access reviews and site application controls.
* Participate in internal audits, customer complaints, and supplier change evaluations.
* Support site regulatory inspections and license filing documentation requests.
* Manage returned goods disposition in line with quality requirements.
* Lead scheduling, minutes, and follow-ups for monthly quality council meetings.
* Actively promote GMP awareness and continuous improvement site-wide.
Required Skills and Qualifications
A degree or post-graduate qualification in science, pharmacy, or engineering is required.
* 3+ years' experience in a regulated pharmaceutical manufacturing environment preferred.
* Experience with quality system ownership, validation, and regulatory audit support is highly desirable.
* Experience in quality management systems such as Veeva, SAP, LIMS, Trackwise.
Benefits
This role offers the opportunity to work with a leading multinational organization in the industry.
Others
Key duties include reviewing change controls and material strategy assessments, providing QA oversight, and actively promoting GMP awareness.
Professionals with a degree or post-graduate qualification in science, pharmacy, or engineering and experience in regulated pharmaceutical manufacturing environments are encouraged to apply.