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Qualified Person - External Manufacturing Animal Health Milton Keynes United Kingdom,  

Posted on : 15 May 2017

Project Description

Qualified Person - External Manufacturing Animal Health-QUA005827DescriptionMSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.The primary purpose of the position is to ensure that licensed veterinary medicinal products within the portfolio, that are supplied to MSD Animal Health 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.The incumbent is accountable for Qualified Person certification and release in accordance with 2001/82/EC and EudraLex Vol IV annex 16. 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 that the partner operates within the agreed upon GMP policies and procedures and in accordance with the Quality elements of the Commercial Agreement, the MSD AH Quality Agreement; ensures the Quality Agreement are kept up to date and ensures review of the Quality elements in the Commercial Agreement " Acts as MSD-AH Quality Operations point of contact to the portfolio third parties and as the Quality liaison between the external partner and the internal company personnel. " Coordinates MSD AH audit plans and effective execution of subsequent remediation by the partner. " Assures approval of the release of (initial) batches of all new products and products undergoing process changes per Council Directive 2001/82/EC, company standard and local regulations. Release of product to market via SAP " Assures Quality requirements on Process Change Requests (PCRs) submitted by the partners and/or Intervet and conformance to all requirements on the PCR are met before approving release of batches made under the changes, " 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 " Point of contact for customer complaints relating to products manufactured in the portfolio and ensure the MSD AH complaint handling process is conducted and documented with all necessary input from the contract partner " Review of the unlicensed non medicinal product manufacturing prior to batch release and release for sale via SAPQualifications " 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 " Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organisational complexity and ambiguityOur employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.Job: Qual Assurce - 3rd Party Manuf Job Title:Assoc. Dir, External QualityPrimary Location: EMEA-United Kingdom-ENG-Milton KeynesEmployee Status: RegularTravel: Yes, 25 % of the TimeNumber of Openings: 1Company Trade Name:MSD Job Segment: Medical, Microbiology, Industrial, Animal Health, Healthcare, Science, Manufacturing, Veterinary


Milton Keynes GB

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