Essential Duties and Responsibilities:

Ø  Execute production activities and ensure strict adherence to cGMP regulations to achieve product processing, preservation, and distribution in compliance with standards.

Ø  Assure that products are manufactured and stored in accordance with prescribed documentation, guaranteeing the attainment of the required quality standards.

Ø  Develop and revise SOP and other pertinent technical documents pertaining to production processes.

Ø  Thoroughly complete Batch Manufacturing Records (BMRs) and all associated documentation for production procedures, strictly adhering to GMP requirements.

Ø  Maintain up-to-date records and promptly update or replace older documents related to the production department as necessary.

Ø  Monitor and manage critical materials, including consumables and reagents, ensuring adequacy and preventing any use of expired items. Notify the production supervisor promptly regarding any concerns.

Ø  Strategically plan the usage of materials and production supplies for the upcoming month.

Ø  Timely update newly issued procedures and records related to the production department, ensuring the real-time accuracy of document records while replacing outdated versions.

Ø  Conduct daily observations of ongoing production processes, promptly reporting any deviations or non-conformance events encountered during batch processing.

Ø  Investigate and report any non-conformance incidents related to production activities promptly.

Ø  Uphold a safe work environment by adhering to established standards, procedures, and regulatory requirements.

Ø  Actively participate in meetings and discussions pertaining to production issues, offering valuable insights and contributions.

Ø  Foster a high level of morale among staff through effective communication and leadership.

Ø  Undertake any additional assigned tasks as required.