QA Validation Specialist

QA Validation Specialist Date: May 28, 2020 Location: Runcorn, GB, WA7 3FA Company: Teva Pharmaceuticals Company Info Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth! Job Description We are recruiting a QA Valiation Specialist to provide expertise for the oversight and governance of the Validation and Sterilisation controls for the Teva Runcorn site. Key Responsibilities: + Identify, design and deliver validation and sterilisation strategies and tactics to support improved application of validation/verification standards. + To provide expert review and approval of validation documentation; ensuring adherence to standards and applicable regulatory requirements and practices. + Ensure the validation of manufacturing and sterilisation systems, filling machines, cleanrooms and packaging equipment meets the required standards. + To ensure oversight of and the timely completion of the requisite tests to maintain the sterilizers within compliance. + Ensure that the thermal qualification, requalification and verification of manufacturing, sterilisation systems, filling machines and controlled environmental spaces adheres to Teva standards and applicable regulatory requirements and practices. + Provide regular updates to departments, Quality and Site Leadership teams of performance measures, propose improvements and escalate any issues, as necessary. + Act as the validation expert for capital projects and new product introduction. + Provide subject matter expert opinion and consultation for problem resolution and auditing. + Provide expertise for the training in validation and qualification practices. Knowledge, Skills and Abilities + Extensive experience working in the pharmaceutical industry + In-depth Sterile Manufacturing experience (essential) + Experience of the Validation 'V-Model' + Well-developed communication skills; ability to influence with all levels of colleagues. + Experience preparing for and presenting to Regulatory Inspectors. + Extensive auditing skills / experience Qualifications + Degree in a scientific discipline Function Quality Sub Function Manufacturing Quality Assurance Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. EOE including disability/veteran