Assoc. Specialist QA

5 months ago


Milton Keynes, United Kingdom MSD Full time

**Position Overview**
- Reporting to the QA Compliance Manager,
- Ensure that production operates in a fully cGMP compliant manner in accordance with the relevant corporate governance requirements (including reporting), policies, procedures and guidelines as well as ensuring that the product and processes are fully compliant with the filed regulatory dossiers for the products supported.

**Secondary** Language(s) Job Description**:
**Duties, Responsibilities, Activities**
- Ensure that all batch related records are reviewed and approved in a timely manner for completeness, accuracy and adherence to Good Documentation Practices (GDP).
- Conduct final review of Seed folders and convey Seeds status to relevant departments.
- Communicating with departments with regards to documentation status; maintaining the document management system (MEDS) by assisting with the review and approval stages.
- Responsible for the implementation, execution and ownership of Quality Systems, including electronic document management, change control and Deviation/CAPA Management
- Implementation of global and site quality procedures.
- Supporting cross-functional departments to assess change control impact and ensuring their timely review, implementation and closure.
- Raising non-conformities, technical incidents and taking suitable and appropriate corrective actions.
- Participate in RCA investigations, developing robust CAPA’s or change controls to rectify the problem and prevent recurrence.
- Mentor and coach stakeholders in cGMP practices to maintain and develop a cGMP environment.
- Perform external/internal audits
- Maintain and promote a state of audit readiness.
- Support and develop other departments to meet GMP requirements and to be audit ready at all times.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R249353


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