Senior Manager Quality Control

4 weeks ago

Irvine, United States The Custom Group of Companies Full time

Senior Manager Quality Control

Responsibilities:

Work with Quality Control teams ensuring that all laboratory operations support the manufacturing operations and Markwins business objectives, and that the laboratory operations comply with all the laws, regulations, and guidance applicable to pharmaceutical drug manufacturing.

Interacts with production management to ensure quality systems are being followed in the manufacturing areas.

Formulate and maintain quality control objectives and coordinate objectives with production procedures in cooperation with other managers to maximize quality and reliability and to minimize costs.

Oversees the daily functions of all quality laboratories.

Oversees reviews and approvals of documentation generated by the labs.

Ensure all documents are kept current and revised as needed.

Create any needed SOPs and review, correct, and improve upon any current SOPs.

Manage and oversee all compliance issues including validation, calibration, etc.

Regulate routine audits of manufacturing areas, laboratories, quality systems, etc. and generate a written report outlining recommendations.

Collaborate with third-party labs to carry out product safety and efficacy testing for both cosmetics. and children's products testing (CPSIA) while remaining within budget and timeline.

Conduct audits of suppliers and third-party laboratories in compliance with FDA cGMP and ISO 22716.

Work in conjunction with other departments manage customer complaints including tracking and close-outs as required by FDA for both OTC and cosmetic products.

Ability to conduct and manage mock and official product recalls.

Interacts with visiting regulatory bodies as needed.

Oversees training program for all employees and maintain related documentation.

Be able to comprehend Markwins' environment of fast production and the need for urgency to get things done without compromising the quality of the product.

Perform other duties as needed and directed by management.

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