Job Description

We are seeking a Quality Assurance Specialist to join our Site Quality Unit based in Milton Keynes. This pivotal role involves ensuring that our production processes operate in full compliance with Good Manufacturing Practices (GMP) and corporate governance requirements. You will work closely with site management and support compliance during inspections, audits, and investigations.

Key Responsibilities:

Review and confirm batch records and quality control results to ensure compliance with production dossiers, procedures, and GMP guidelinesCommunicate effectively with various departments regarding the status of batch documentation and prepare necessary documentation for Qualified Person (QP) reviewReview deviations and Corrective and Preventive Actions (CAPAs) as the QA representative and participate in cross-functional investigationsMaintain the change control system, working with departments to assess impacts and ensure timely review, implementation, and closureReview and approve operational procedures across departments, ensuring that Quality Assurance Standard Operating Procedures (SOPs) are clear and up to dateConduct self-inspections and participate in corporate audits and regulatory inspections

Qualifications, Skills & Experience:

Bachelor’s degree or equivalent in a relevant field, coupled with experience in cGMP and quality management systemsExperience in the pharmaceutical industry, specifically within Quality AssuranceFamiliarity with pharmaceutical manufacturing processesProficiency in technical report writing and database managementIn-depth knowledge of current regulatory requirements for the manufacture of licensed medicinal products

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/6/2025

*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.

Requisition ID:R327106