Quality Assurance Supervisor

A start-up Pharmaceutical company seeking a Quality Assurance Supervisor for their Pharmaceutical manufacturing facility in Inland Empire, California. The successful candidate will play a key role in implementing quality of Dietary supplements and OTC drug products in a manufacturing environment.
Job Requirement

Create and Establish a scientific approach to the company quality system.
Ensure all GMP, GLP, GCP operations are in compliance,
Establish training and audit programs, create and review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports and Master manufacturing records.
Develop strategies for and introduce quality policies to set up system and documentations.
Manage the manufacturing team in terms of product quality and provide them cGMP training.
Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval.
Provide periodic update on regulatory requirement changes, which affect individual product specification or quality systems.
Foster collaborative, efficient and effective working relations with regulatory authorities such as FDA.
Manage external contract laboratory for contract testing.
Be responsible for release or rejection of cGMP materials and utilize QA staff to manage the timeline and assure on time delivery of approved materials.
Act as company’s representative during regulatory agencies and customer inspections


Qualifications

BS degree in Pharmacy, Chemistry, Life Science or related discipline and a minimum of 5 years of relevant Quality compliance experience in Dietary supplement and OTC drug products.
Familiar to solid dosage pharmaceutical manufacturing process with thorough understanding in GMP, GLP, GCP.
Expertise in OTC products documentation as per 21CFR part211.
Experience in effectively managing FDA inspections and customer audits.

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Reference number US_EN_2_025142_141430