Job Description:
The Quality Specialist plays a crucial role in supporting the Quality Systems activities within both the Drug Substance and Drug Product facilities. This individual is responsible for providing leadership, guidance, and expertise to ensure compliance with validation standards and policies.
Key Responsibilities:
* Sub System Ownership: Complete sub system ownership responsibilities as per the site System Ownership list.
* Quality SME for Process, Cleaning, Water, Equipment: Provide technical assistance and support as a member of the project teams, and ensure that validation status is maintained following changes/modifications.
* SAP Quality Process Steward: Principle Quality contact for all site change requests (with impact on processing) and provide Quality and change analyst review for all change requests through all the stages of the change control process.
* Laboratory QA oversight: Support and approve the systems supporting laboratory functions, instrumentation and GLIMS.
* Stability oversight: Review and approval of stability reports (Intermediate and API stability data and reports are reviewed for accuracy and to support OOS and investigations as appropriate).
* Microbiology Point of Contact: Liaise with site Microbiologist for all microbial issues.
* Quality Agreement System Management: Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships.
* Annual Review System Management: Ensure that Annual Reviews (AR/APR/PQR) for products and systems incl automation, are completed to meet the Annual Review schedule.
* Quality Oversight: Approve all designated user access reviews, ensuring compliance with site and company policies and procedures.
* Supplier Change Evaluations - Quality Role: Review and approve Supplier Change Evaluation documentation.
* Supplier and Customer complaints: Participate in the investigation and review of any internal / external customer complaints in accordance with agreed lead-times.
* Filing & Licence maintenance and Regulatory Requests follow ups: Review and ongoing maintenance of site licences, and provide site documentation to support product filings in accordance with CMC requests.
* Returned Goods: Manage the segregation and disposition of all returned goods.
* Audit program: Support the internal GMP walk-down and scheduled audits program.
Requirements:
* Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field
* Validation principles and guidelines
* Understanding of key business drivers and decision-making skills
* Technical report writing skills
* Computer Applications: Word, Excel, Access, eLogs, File and Email Management
* Meetings Management
* Analytical Problem-solving skills applied to issue identification and resolution
* Continuous improvement skills