摘要
About the Role
QUALIFICATIONS AND JOB DESCRIPTION
•Ensure that GMP/GLP requirements defined by MOH, Novartis Global Procedures completely and effectively implemented
•Lead and coach the product control analyst team
•Prepare and update SOPs, ensure that actions are managed according to SOPs and give the trainings of the revised SOPs
•Control and approve all documents associated with Product Control Laboratory
•Prepare weekly analysis plan for drug products and follow up
•Control raw data and worksheets
•Make usage decision in SAP system for drug products in accordance with the KPI (key performance indicator) and target release date
•Report and investigation of all OOS, OOE OOT and deviations according to the Novartis SOPs
•Performing of all ‘’Change Control Process’’ evalsuation and execution actions regarding Product Control Lab on time
•Provide and apply SOP rules about HSE requirements security preventions on time
•Define and take the necessary precautions in terms of working safety
•Define and provide IQP projects. Identify productivity opportunities within the Product Control lab and support the implementation
Minimum Requirements
•University degree in Pharmacy, Chemical Engineering or Chemistry
•Minimum 6 years of Laboratory experience with equipment e.g. HPLC, GC, UV/Vis and Wet Chemistry at a pharmaceutical company. Non-sterile oral dosage form drug product test experience is preferred
•Knowledge of cGMP& cGLP and SAP
•Good command of English is required
•Strong communication skills and leadership presence
•Ability to work in a fast-paced changing environment
•Team working and customer oriented mindset
•Good analytical thinking skills
•Good knowledge of MS Office applications
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
