Quality Assurance Head Operations
As Quality Assurance Head Operations, you will be responsible for managing quality aspects to ensure operational compliance with cGMP, the Quality Assurance Agreement, regulatory requirements, and the Novartis Quality Manual. Your responsibilities include, but are not limited to:
- Implementation and continuous improvement of compliance with quality standards
- Responsible for Annual Product Quality Review
- Process of release of intermediates and finished products
- Approval of documents related to products and manufacturing processes
- Management of customer complaints and product returns
- Reporting indicators to Sandoz GQA
- Management, organization, and leadership of customer audits
- Supervision in new projects requiring Quality Assurance Operations
Minimum Requirements:
- Educational Background: Pharmacist (mandatory)
- Technical Director/Qualified person
- At least 5 years’ experience in QA/QC/Production within the Pharmaceutical industry, especially in Aseptic/Environmental sector
- Excellent knowledge of Quality Assurance/cGMP requirements in USA, EU
- Aseptic knowledge
- 3-5 years’ professional experience in Pharma/Manufacturing sector in an analytical lab in a GMP environment or equivalent
- Expertise in GxP operations, Management of Quality Audit, Quality Change Control, Good Documentation Practice, Aseptic Manufacturing Operations, Inspection Preparedness
- Fluent in English and Spanish
You’ll receive:
- Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme
Why Sandoz:
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020. We believe new insights and solutions can be found at the intersection of medical science and digital innovation. We aim to pioneer access to medicines globally through an unbossed culture underpinned by integrity, curiosity, and flexibility. Join us to tackle the world’s toughest medical challenges!
Division: Novartis Technical Operations
Business Unit: NTO QUALITY
Country: Spain
Work Location: Barcelona Palafolls
Company/Legal Entity: Sandoz Industrial Product
Functional Area: Quality
Job Type: Full Time
Employment Type: Regular
Shift Work: No
Early Talent: No
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Más información
- Address Barcelona
