摘要
About the Role
- Major accountabilities:
- Planning and supporting PQR/APQR activities
- Support site qualification and validation activities (planning, advising, review)
- Implementation of Quality Systems (incl. documentation management) -Supplier management activities (agreements, oversight, audit)
- Preparation/support and coordination of CAPA/follow-up
- Audit and inspection preparation and support
- Change control review/approval -Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.)
- Ensure process quality assurance acc.
- to regulations ,QP declaration review and approval,
- KPI trending.Ensure applications, certificate maintenance etc. to local HA -SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country
Key performance indicators:
- Ensures planning and successfully supports PQR/APQR activities
- Successfully carries out site qualification and validation activities (planning, advising, review)
- Supports the implementation of Quality Systems (incl. documentation management);
- Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc)
- Ensure process quality assurance according to regulations
Minimum Requirements:
Work Experience:
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
- cleanliness zones.
- Functional Breadth
Skills:
- Action Oriented.
- Continuous Learning.
- Dealing With Ambiguity.
- Functional Skills.
- Gmp Procedures.
- Process Optimization.
- Qa (Quality Assurance).
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
- GxP.
- Industry standards.
- Compliance requirements.
Languages :
- English.
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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.
