摘要
About the Role
Major accountabilities:
- Revise existing or create new SOPs in time to support Manufacturing Strategy.
- Ensure periodic review is completed on time
- Coordinate updates with cross functional teams for CAPAs, QEs, Health Authority inspections
- Ensure proper training compliance of all associates in
- Develop appropriate Individual training plans in collaboration with team leads
- Stay current regarding industry standards and ensure that all SOPs are cutting edge and incorporate all latest regulatory and quality requirements
- Support Quality Manual implementation through support of gap assessments and implementation of relevant content into SOPs and daily operation.
Key performance indicators:
- MBR right first timeReduction of batch record cycle timeReduction of operational errors98% training compliance of all associatesNo critical audit findings pertinent to SOPs/MBRs
Work Experience:
- 3-5 or more years of related experience in cGMP/FDA regulated industry.
- Pharmaceutical GMP's – strong knowledge of Good Manufacturing Practices and regulatory knowledge is a requirement.
- Proficient in MS Office applications and other related IT Systems.
- Knowledgeable in ESOPs; LMS (Learning Management Systems),
- TrackWise; MES knowledge is a plus
Skills:
- Assembly Language.
- Cooperation.
- Efficiency.
- Electronic Components.
- Flexibility.
- General Hse Knowledge .
- Good Documentation Practice.
- Installations (Computer Programs).
- Iso (International Organization For Standardization).
- Job Description.
- Knowledge Of Gmp.
- Lean Manufacturing.
- Manufacturing (Production).
- Manufacturing Process.
- Nuclear Medicine.
- Physics.
- Product Distribution.
- Production Line.
- Scheduler.
Languages :
- English.
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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Accessibility and accommodation
Novartis is committed to work with and provide 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.
