Teva MS & Senior SME 

United Kingdom, England 

95862454

Key Responsibilities:

• Subject matter expert (SME) in aseptic processing, compounding, filling, device assembly and packing of sterile products.

• Provide senior technical expertise and leadership in new product introduction, technology transfer and ongoing support for commercialised products.

• Perform technical and scientific evaluation, risk assessment, troubleshooting and recommend solutions related to all aspects of pharmaceutical operations in support of site changes and commitments to regulatory agencies.

• Lead complex investigations and resolve manufacturing challenges.

• Maintain an up-to-date knowledge of key regulatory guidance and industry best practice, recommending and implementing changes as appropriate across site.

• Able to build and maintain a strong network of internal and external SMEs to drive continued best practice.

• Professionally support and motivate collaborators at all levels to increase competency, efficiency of equipment, process and procedures for manufacturing / packaging operations.

• Providing senior leadership on specific initiatives and/or projects to increase process reliability, productivity, capacity and quality/compliance to meet the most up to date regulations.

• Takes a leading role in the development of technical training and cross-department skills (primarily focused on MS&T).

• Support site regulatory audits and continuous audit readiness.

• Perform all job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) instructions.

Do you have?

• Qualification to minimum degree level (or equivalent) in a relevant technical discipline
• Extensive technical experience in a senior role within a sterile / aseptic pharmaceutical manufacturing environment.
• Significant experience in the Aseptic processing, Management of Change, and continuous improvement of people and processes. Desirable experience in device technology.
• In depth knowledge of cGMP and Quality Systems, including Quality By Design, Change Control, Non-Conformances, CAPAs, Deviations, Validation and Regulatory guidance.
• Strong technical aptitude in manufacture of complex pharmaceuticals, Technical Transfer/new product lifecycle regulatory requirements.
• Proficiency in aseptic processing, sterilization technologies and processes, Clean Room Technology and Behaviours, Media Simulation Studies and the generation of Sterility Assurance Packages.

Are you?

• A confident communicator with excellent verbal, written, and interpersonal skills.
• Computer literate across SAP, MS Word, Excel, Project, PowerPoint, Trackwise, JMP, and Visio.
• Bringing technical report writing, data evaluation and decision-making skills in ambiguous situations.
• Assertive with the ability to manage change, influence and persuade key stakeholders with proactivity and enthusiasm.

• 25 paid holidays per year with the option to buy and sell up to 5 days annual leave each year
• Private healthcare scheme through Bupa for you and your partner
• A formal training and development programme specific to your role and department
• Company pension – flexible employee and employer contributions
• Competitive salary
• Employee assistance programme
• A number of health benefits including: Life Assurance, Critical Illness Insurance, Income protection
• Plus many other flexible benefits via salary sacrifice: Cycle to work scheme, online and in store discounts and much more

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.