Production Documentation Specialist
3 settimane fa
Purpose and Scope
The Production Documentation Specialist will oversee the management of all activities related to production documentation ownership, ensuring cGMP compliance and the execution of related training. This role will be responsible for executing documentation revision, issuance, and maintenance according to GDDP rules.
Key Responsibilities
- Execute effective training of Production documentation of its ownership.
- Execute Change Control activities with impacts on production and support those through adequate and strong risk assessment.
- Collaborate with regulatory authorities' audits.
- Execute production activities as support to process, cleaning validation and technical operation activities with impact on Production process/equipment.
Requirements
- Degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
- 3-5 years of experience in pharmaceutical companies.
- Deep knowledge of aseptic production process and GMP regulations.
- Organizational, analysis and prioritization ability.
- Communication skills, ability to influence other.
- Flexibility, ability to rapid adaption to changes.
- Ability to take/propose decisions based on risk evaluation.
- Strong team-working ability and results orientation.
- Problem solving ability.
- Good knowledge of English and of the main IT applications (Word, Excel, Power Point).
About Takeda
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, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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