Manufacturing Deviation And Gmp Documentation Lead Pisa

Manufacturing Deviation And Gmp Documentation Lead
Pisa
Toscana, Pisa

Manufacturing Deviation and GMP Documentation Lead, Pisa Client: Takeda

Location: Pisa

Job Category: Manufacturing

EU work permit required: Yes

Job Reference: 6f2ce0f08dac

Job Views: 11

Posted: 22. 01. 2025

Expiry Date: 08. 03. 2025

Job Description: Description Job Title: Manufacturing Deviation and GMP Documentation Lead

Location: Pisa

Assure management of all activities related to GMP production documentation, including:

Critical revision, approval, issuance, and maintenance of documentation according to GDDP rules and cGMP compliance.

Execution of training on production documentation (SOPs, MBRs, JA, etc. )

with strong training efficacy.

Logistic activities for manufacturing and visual inspection.

Revision of production documentation per GDP compliance.

Data management for trending purposes.

Management of Production Deviation, including investigation and CAPA.

Identification of gaps in manufacturing/visual inspection and execution of optimization on the shop floor.

Collaboration for audit execution.

Management of direct personnel involved in production documentation, logistic activities, deviation management, and optimization.

Setting objectives and providing guidance to subordinates to achieve goals in accordance with established policies.

Minimum Qualifications: Degree in scientific disciplines (Chemistry, Pharmaceutical Technologies, Biology, Biotechnology).

At least 5 years of experience in pharmaceutical companies with deep knowledge of aseptic production processes.

Deep knowledge of GMP regulations and manufacturing of sterile products with RABS and Isolators.

Good knowledge of English and main IT applications (Word, Excel, PowerPoint).

Previous use of Trackwise System is a plus.

Familiarity and appetite for the digitalization of systems/processes.

Strong relationship and communication skills with the ability to influence others.

Ability to make independent decisions based on data evaluation and risk assessment.

Strong team-working ability, results orientation, and problem-solving skills.

More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.

We foster an inclusive, collaborative workplace, united by our commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to any characteristic protected by law.

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