Qualified Person

Merck; Milton Keynes; On-site; GBP 40,000 - 80,000; Full time

Job summary

An innovative organization is seeking a Qualified Person to join their Animal Health division in Milton Keynes. This pivotal role involves ensuring compliance with GMP standards, overseeing the certification of drug products, and acting as a key contact for regulatory inspections. The ideal candidate will possess a degree in a relevant biosciences discipline and have experience in batch certification. Join a forward-thinking company committed to quality and continuous improvement, where your expertise will contribute to the success of their operations and the health of animals worldwide. This is a fantastic opportunity to make a significant impact in a vital industry.

Qualifications

• Degree in relevant biosciences discipline required.
• Experience in EU Qualified Person batch certification is essential.
• Strong stakeholder management skills are necessary.

Responsibilities

• Ensure compliance with GMP and QMS across UK sites.
• Act as a point of contact for QP certification and batch release.
• Mentor others to enhance site compliance knowledge.

Skills

GMP/GCLPs Knowledge

QMS

Test Method Validation

Lean and Six Sigma

Communication Skills

Problem Solving

Organizational Skills

Teamwork

Education

Degree in Pharmacy

Degree in Chemistry

Degree in Biology

Job description

Our organization Animal Health is now recruiting a Qualified Person position at our site in Milton Keynes for our Animal Health division.

The suitable candidate will have duties as below:

• 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 Pharmacuetical manufacturing QA is desirable but not essential.
• Post graduate experience in pharmaceutical manufacturing either in a QA or QC role.
• 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

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

Job Description

Our organization Animal Health is now recruiting a Qualified Person position at our site in Milton Keynes for our Animal Health division.

The suitable candidate will have duties as below:

• 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 Pharmacuetical 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

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):

Job Posting End Date:

05/24/2025

*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.