Quality Assurance Professional
This is an exciting opportunity to join a leading multinational organization as a Quality Assurance Professional.
The role requires the professional to support quality activities in both drug substance and drug product facilities.
* 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.
Responsibilities:
* Validation
* Quality assurance
* Regulatory compliance
* Continuous improvement
Benefits:
* Opportunity to work in a dynamic industry
* Chance to develop skills and expertise
* Collaborative team environment