MSD Senior Technician - Quality Assurance 

United Kingdom, England 

546764190

Job Description

Supported by the Quality Compliance Team and the Quality Systems Team and the Qualified Persons located in Milton Keynes, the Senior QA Technician will provide essential support to ensure that production operations adhere to Good Manufacturing Practice (GMP) compliance and regulatory requirements.

Key Responsibilities:

• Review and approve batch related records in a timely manner and prepare release proposals for batches, including the review of any related deviations
• Communicate with relevant departments regarding the status of batch documentation and ensure effective coordination
• Assist in SBB, NSBB, FPU, QC operations and maintain the change control system, efficiently assessing and implementing necessary changes.
• Act as the quality representative for investigations, assign actions, raise Corrective and Preventative Actions (CAPAs), and oversee change control when applicable
• Perform internal and external inspections and audits, and participate in regulatory inspections as required
• Coordinate VMD amendments
• Act as a contact within the QA officer team for review-related matters and work with team members to resolve issues
• Identify continuous improvements for QA procedures and documentation, while also facilitating projects outside the QA Integrated Process Team (IPT)
• Conduct QA activities on the shop floor and monitor the safety culture within the department

Qualifications, Skills & Experience Required:

• A graduate or equivalent with experience in cGMP and working within a quality management system
• Demonstrated knowledge and understanding of current regulatory requirements for the manufacture of licensed medicinal products
• Internal Audit Experience desirable
• Proficient in problem-solving and possess excellent communication skills.
• Knowledge of MPS tools, technical report writing, and database management is desirable
• Familiarity with pharmaceutical manufacturing processes is desirable

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.