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Job Description
Our Animal Health organisation are recruiting for a Qualified Person at our site in Milton Keynes.
Job Description
Our Animal Health organisation are recruiting for a Qualified Person at our site in Milton Keynes.
Key Responsibilities
* Undertakes the duties of a Qualified Person as defined in Directives 2001/82/EC
* Responsible for the QP certification of Drug Product and Intermediates in accordance with UK Code of Conduct for Qualified Persons, acting as a point of contact for queries relating to QP certification and batch release
* Working with the Quality Compliance Manager to provide an efficient and effective service to support the timely release of materials, components and products including UK Commercial and imported products controlled by the sites
* Working with the site management, ensuring that the UK sites operate in a fully GMP compliant manner in accordance with all of the relevant legislation, corporate governance requirements (including reporting), policies, procedures and guidelines as well as ensuring that the products and processes are fully compliant with the filed regulatory dossiers for the products supported.
* Working with the Quality Systems Manager ensuring that the Quality Management System (QMS) is fit for purpose, as far as practicable harmonized across the sites and in compliance with global policies
* Engage in self inspection of the site QMS
* Act as a GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Pharmaceutical Quality System. Mentor others to expand on-site compliance knowledge
* Supporting senior QA leadership through QP decision making to drive continuous improvement and ‘fitness for purpose’
* Partners with and supports other sites and functions as needed during the technical transfer of products into and out of the site
* Partners proactively with other sites within the supply chain to ensure that products and intermediates are received, released and shipped in a timely and fully GxP compliant manner
* Acts as the point of focus for all compliance inspections of the sites e.g. internal and corporate audits as well as Regulatory Inspections
* Either directly or through colleagues, liaises with the Veterinary Medicines Directorate (VMD) regarding the routine release of biological products and at other times to secure the resolution of complaints and other issues that might impact the quality and supply of the products supplied by or for the company
Qualifications, Skills & Experience Required
* Degree in Pharmacy, Chemistry, Biology or relevant biosciences discipline.
* Eligible for nomination as a Qualified Person
* Experience in performing EU Qualified Person batch certification
* Experience of Sterile Product Pharmaceutical manufacturing QA is desirable but not essential
* Post graduate experience in pharmaceutical manufacturing either in a QA or QC role
* Supervisory or management experience desirable
* Auditing experience desirable
* Proven technical ability including knowledge of GMP/GCLPs, QMS, test method validation & equipment qualification, continuous improvement/business excellence and Lean and 6 Sigma is desirable
* Excellent interpersonal skills including good communication, conflict management and leadership
* Excellent decision-making and problem solving skills
* Excellent organisational & planning skills
* Ability to work in team and solo capacity
* Strategic and hands on approach to driving a Quality Culture and Improvements across site including mentoring individuals
* Pragmatism and strong stakeholder management skills
Closing date for applications 16th July 2025
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
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Not Applicable
Shift
Valid Driving License
Hazardous Material(s)
Required Skills
Batch Releases, Batch Releases, Change Management, Computer System Validation (CSV), Corporate Governance, Decision Making, Driving Continuous Improvement, GMP Compliance, GMP Laboratory, Governance Reporting, Immunochemistry, Internal Inspection, IS Audit, Management Process, People Leadership, Performance Qualification (PQ), Pharmaceutical Manufacturing, Quality Assurance (QA), Quality Auditing, Quality Control Documentation, Quality Management, Quality Management Standards, Quality Management System Auditing, Quality Management Systems (QMS), Quality Risk Management {+ 5 more}
Preferred Skills
Job Posting End Date
07/16/2025
* 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 R355226
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Other
* Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services
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