Manufacturing Specialist Role
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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.
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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.
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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.
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Responsibilities:
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1. Review and approve new and updated Master Batch Records and Electronic Batch Records
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2. Provide presence on the shop floor to support compliance and data integrity
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3. Review and approve production documentation and SOPs
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4. Actively participate in Tier process and QA support for Commissioning and Qualification lifecycle documents
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5. Collaborate with cross-functional teams on continuous improvement initiatives
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6. Support internal audits and regulatory inspections
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7. Drive continuous improvement and utilize problem solving tools
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8. Participate in training and development programs to enhance skills and knowledge
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9. Contribute to the development and implementation of quality strategies and policies
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Education and Experience:
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10. Bachelor degree in a scientific or engineering field
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11. Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment
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12. Strong understanding of QA operations, GMP systems, and pharmaceutical manufacturing processes
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13. Experience in authoring and approving GMP documents
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