Qualified Person - External Manufacturing
Company: ProClinical Ltd
Closing Date: 01 Mar 17
Salary (£): Competitive
Our client, a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products, is seeking a Qualified Person (External Manufacturing) to join their team. As part of their global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. This is a permanent position based in Buckinghamshire, UK. ...
Our client, a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products, is seeking a Qualified Person (External Manufacturing) to join their team. As part of their global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. This is a permanent position based in Buckinghamshire, UK.
- The primary purpose of the position is to ensure that licensed veterinary medicinal products within the portfolio, that are supplied from European Contract Manufacturers are manufactured, packaged, analyzed and distributed in conformance to company and regulatory guidelines and meet both internal and external customer demands.
- Ensuring all batches of product have been manufactured in accordance with the Licensed Marketing Authorisation, the Product Quality Specifications and Good Manufacturing Practices (GMP) before released for sale.
- Additionally there are a number of unlicensed non medicinal products in the portfolio which although not formally licensed, require review and release by quality assurance eg biocides.
- The incumbent is responsible for the direct oversight of total quality performance and operations of such Third Party Operations through direct support and technical advice, guidance, counselling to the site Quality Operations Manager or Director as well as on-site supervision.
- The incumbent exercises a leadership role in monitoring and maintaining the Third Party compliance with Current Good Manufacturing Practices regulations and other pertinent legal requirements.
- Reports to the Quality Lead for External Manufacturing (Animal Health) EMEA Region and is a member of the Quality External Manufacturing team.
- Receives guidance and direction when necessary; discharges all responsibilities independently.
- Keeps the Quality Lead informed on the status of operations and when challenges, opportunities and/or issues arise.
- Assures on-site guidance is provided to the partner in the preparation of Quality Systems, procedures and guidelines as applicable; ensures robust systems for supplier and CMO management oversight exist ? Assures QO participation in the on-site demonstrations of new processes/products for transfer of analytical procedures and technology to the partner.
- Enforces established validation requirements to assure that the process is under control and in compliance with registered procedures.
- Makes on-site decisions as to the quality of the product/process and ability of site to perform quality validation and testing,
- Ensures that ongoing validation programs of third party operations for in-line products are implemented on a timely basis, according to Intervet Standards and local regulations. This includes semi-annual media challenges, periodic revalidation of equipment, installation and operation qualification for new installations and product annual reviews.
- Ensures proactive support in training and coaching to initiate quality improvements within the partners Operations
- Review of the unlicensed non medicinal product manufacturing prior to batch release and release for sale via SAP Qualifications
- Bachelor degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent);
- Qualified Person is essential for this role (ideally with 3-5yrs experience as a QP certification and release of pharmaceutical products
- Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
- Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management;
- Must have the ability to influence management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
- Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs and regulatory issues
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.