
Operations Excellence Manager
2 weeks ago
Manufacturing Specialist Role
\As a key member of our team, you will provide direct support to production areas and contribute to the development and implementation of quality strategies.
\The ideal candidate will have a strong background in GMP manufacturing and quality assurance, with experience in reviewing and approving documents such as Master Batch Records and SOPs.
\You will work closely with cross-functional teams to ensure compliance with cGMPs and company procedures, and participate in continuous improvement initiatives to enhance operational efficiency.
\Responsibilities:
\- \
- Review and approve new and updated Master Batch Records and Electronic Batch Records\
- Provide presence on the shop floor to support compliance and data integrity\
- Review and approve production documentation and SOPs\
- Actively participate in Tier process and QA support for Commissioning and Qualification lifecycle documents\
- Collaborate with cross-functional teams on continuous improvement initiatives\
- Support internal audits and regulatory inspections\
- Drive continuous improvement and utilize problem solving tools\
- Participate in training and development programs to enhance skills and knowledge\
- Contribute to the development and implementation of quality strategies and policies\\-
Education and Experience:
\- \
- Bachelor degree in a scientific or engineering field\
- Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment\
- Strong understanding of QA operations, GMP systems, and pharmaceutical manufacturing processes\
- Experience in authoring and approving GMP documents\\-
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