Sammanfattning
Performs QA oversight of production and testing activities (shop-floor presence), ensuring compliance with cGxP and ISO9001 standard. incl. DI and eCompliance, eg. as OQA SPOC. Acts as reviewer/approver of production and QC records and documents, incl. MBR. Provides specialist support in the evaluation and execution of the investigations and changes.
About the Role
Key Responsibilities：
- Provide shop-floor QA support and oversight of production and testing activities, ensures compliance with cGxP, ISO9001, incl. data integrity and eCompliance
- Batch document review, support product release
- Support deviation and compliant investigations within MU, QC, Engineering and warehouse and other relevant areas.
- Performs routine documentation activities, Review and approval of production and QC documents and records, MBR review
- Supports change control activities
- IPC oversight
- Support OpEx improvement projects
- Support internal and external audit or inspection activities
- Comply with all HSE guidelines. Detect and report potential accident, risks and propose solutions. Participate in HSE risk assessments. Preparation and participation to internal HSE audits
- Responsible for participating in initial training and retraining
Essential Requirements:
- University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
- Qualified Person (depending on local requirements)
- Good (oral and written) in English; fluent in local language (oral and written)
- More than 3 years of experience in pharmaceutical quality control, quality assurance or production
- Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
