Job Description
Key Responsibilities:
Engineering & Maintenance Leadership:
Lead the overall engineering function for API operations, ensuring smooth plant operations and regulatory compliance.
Develop and implement engineering strategies to optimize production efficiency, minimize downtime, and ensure cost-effective maintenance.
Drive the preventive and predictive maintenance programs for all critical equipment and utilities.
Regulatory Compliance & Audit Readiness:
Ensure the engineering function complies with USFDA, EU GMP, MHRA, and other global regulatory standards.
Play a key role in handling USFDA and other regulatory audits as the Engineering Head, ensuring all compliance requirements are met.
Maintain audit readiness by implementing best practices in equipment qualification, validation, and documentation.
Ensure that containment systems and OEL study protocols are in compliance with regulatory a...
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