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Job Description

Sarà considerato requisito preferenziale l'appartenenza alle categorie protette (legge n. 68/99)

Job Title: Manufacturing Deviation & GMP Documentation Supervisor

Location: Pisa

OBJECTIVES/PURPOSE:

• Supervision and management of all activities related to all GMP production documentation; that includes:

• critical revision, approval, issuance, maintenance of documentation according to GDDP rules, cGMP compliance.
• execution of training on production documentation (SOPs, MBRs, JA, etc.) by assuring strong training efficacy.
• llogistic activities for manufacturing and visual inspection.
• revision of production documentation per GDP compliance.
• data management for trending purpose.

• Supervision and management of Production Deviation, that includes investigation and CAPA.
• Supervision and management of identification of gaps in manufacturing/visual inspection to fix those; supervise/identify/execute optimization on the shop floor.
• Collaboration for audit execution.
• Management of direct people involved in Production documentation, Logistic activities, Deviation management, optimization on the shop floor, identification/resolution of gaps in manufacturing and visual inspection.
• Person in charge for security.

ACCOUNTABILITIES:

• Guarantee Production documentation critical revision approval, issuance, maintenance (Master Batch Records, SOPs, forms, logbooks, visual aid) according to GDDP rules and cGMP compliance.
• Guarantee execution of training on Production documentation of its ownership/department by assuring strong training efficacy.
• Guarantee logistic activities for manufacturing and visual inspection (preparation and distribution of MBRs and VRs, creation of sampling labels), revision of production documentation per GDP compliance, data management for trending purpose.
• Supervise/execute/lead investigations related to manufacturing/visual inspection department, applying appropriate tools (i.e.: DMAIC); supervise/identify/execute related CAPAs when applicable.
• Collaborate with regulatory authorities’ audits.
• Supervision and management of identification of gaps in manufacturing/visual inspection to fix those; supervise/identify/execute optimization on the shop floor.

CORE ELEMENTS RELATED TO THIS ROLE:  

• Ability to take independent decisions based on risk assessment evaluations; critical thinking, problem solving, apply scientific approach.
• Focus on innovative/alternative solutions compliance with GMP requirements and based on risk assessment approach; collaborate with operators on the floor to conciliate operations and quality/regulatory requirements.
• Digital/innovation oriented.
• Focus on respect of manufacturing/visual inspections time constraints; ability to manage logistic activities following changes in manufacturing scheduling.
• Strong ability on relationship/communication skills with colleagues intra/inter- department, and to lead/guide team; be recognized as a lead.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

At least 3 years of experience in pharmaceutical companies and deep knowledge of aspetic production process. Deep knowledge of GMP regulations and manufacturing of sterile products with RABS and Isolators.

Leadership

• Strong organizational and personnel management skills.
• Strong relationship and communication skills, ability to influence other.
• Data analysis.

Decision-making and Autonomy

• Ability to take indipendent decisions based on data evaluation and risk evaluation.
• Strong team-working ability and results orientation.
• Strong problem solving ability.

Interaction

• Strong inter-group work skills (Engineering, Quality, Supply Chain, Validations, Training, etc.), inter-facility work-skills (Rieti, Vienna).

Innovation

• Deep knowledge of GMP with respect to the production processes in aseptic conditions.
• Good knowledge of English and of the main IT applications (Word, Excel, Power Point). Use of Trackwise System.
• Oriented in digitalization of systems/process.

Complexity

Understand business needs and conciliate those with GMP requirements.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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