Manufacturing Documentation and Compliance Specialist
2 giorni fa
About the Role:
Takeda is seeking a highly skilled Manufacturing Deviation and GMP Documentation Lead to join our team in Pisa, Italy.
Job Summary:
The Manufacturing Deviation and GMP Documentation Lead will be responsible for managing all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance.
Main Responsibilities:
- Assure management of all activities related to GMP production documentation, including critical revision, approval, issuance, maintenance of documentation according to GDDP rules, cGMP compliance.
- Execute training on production documentation (SOPs, MBRs, JA, etc...) by assuring strong training efficacy.
- Manage logistic activities for manufacturing and visual inspection.
- Revise production documentation per GDP compliance.
- Manage data for trending purposes.
- Assure management of Production Deviation, including investigation and CAPA.
- Identify and execute optimization on the shop floor.
- Collaborate with regulatory authorities' audits.
- Manage direct people involved in Production documentation, Logistic activities, Deviation management, optimization on the shop floor, identification/resolution of gaps in manufacturing and visual inspection.
Requirements:
- Degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
- At least 5 years of experience in pharmaceutical companies and deep knowledge of aseptic production process.
- Deep knowledge of GMP regulations and manufacturing of sterile products with RABS and Isolators.
- Good knowledge of English and of the main IT applications (Word, Excel, Power Point).
- Familiarity with digitalization of systems/process.
- Strong relationship and communication skills, ability to influence others.
- Ability to take independent decisions based on data evaluation and risk evaluation.
- Strong team-working ability and results orientation as well as strong problem-solving skills.
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