Project Coordinator
1 mese fa
In the realm of production, management of documentation is crucial. This encompasses the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications, all in strict adherence to GDDP and cGMP standards. As a subject-matter expert, overseeing production changes and conducting related risk assessments is important. Moreover, leading projects that enhance production processes and continuous improvement initiatives are key responsibilities. Collaborating on audits further ensures compliance and excellence in production standards.
Key Responsibilities- Complete: Electrical Manufacturing Batch Record (MES), Equipment Specification (ESP) and related procedures revision, approval, issuance and related SOPs, according to GDDP rules and cGMP compliance.
- Implement training of Production documentation of its ownership.
- Be part of the execution of the Change Control as SME for production and support those through risk assessment (quality risk management).
- Collaborate with regulatory authorities' audits.
- A degree in Chemistry, Pharmaceutical Technologies, Biology, Biotechnology, or related engineering fields.
- Experience in pharmaceutical industry, especially in aseptic production.
- Regulatory Knowledge: Proficiency in GMP regulations, sterile manufacturing, RABS, and Isolators.
- Analytical Skills: critical thinking, problem-solving, and application of scientific methods.
- A team player able to collaborate across dynamic departments.
- Technological Proficiency: Digital and innovation orientation, familiarity with IT applications like Word, Excel, PowerPoint, and Trackwise System.
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Project Coordinator
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