Quality Manager - Pharmaceuticals

Quality Manager

Quality Manager

Develops and deploys the quality system for manufacturing facilities and must have a good understanding of Laboratories practices to assure systems and procedures are compliant with government regulations, industry standards and Company specifications and policies. He / She is responsible for working with other quality managers and operations management to align Material handling, equipment cleaning, room cleaning with process flows in manufacturing and packaging operations.

The SQM must have a very good understanding of GMP requirements and regulations relating to Dietary supplements manufacturing and Preventive controls for Animal Food (21 CFR Part 111 and 21CFR Part 507)

Ensures Quality processes relating to manufacturing and packaging including all cleaning procedures in all facilities.

Work closely with operations management to ensure work instructions are appropriate for the different work centers.

Responsible for Aligning batch record with work instructions / OJT as well as in-process Quality checks in all product manufacturing (Tableting, Encapsulation, Powders, liquid filling, soft chews, pellets etc)

Establish standards in areas where necessary.

The SQM will work very closely with Supply Chain to manage raw materials release and availability for manufacturing operations in all facilities.

Lead internal and external audits as they pertain to the Microbiology Laboratory and assist with developing strategies when addressing audit findings

Lead or oversee all product or situation investigations relevant to Manufacturing operations

May act as the Management Representative for Quality when necessary

Develops and deploys the Quality systems (e.g. CAPA, design control, process control) to ensure products conform to defined requirements.

Manages team for regulatory inspections...

Manages quality compliance for Contract Manufacturers

Communicate effectively with other departments within the organization and function within a team environment.

Regular attendance is required.

Perform other assigned duties as may be required in meeting company objectives

Minimum Requirements :

• A strong understanding of Quality Control testing and Quality Assurance processes.
• Thorough working knowledge of industry regulations, FDA, USP, AOAC, and ICH guidelines; experience implementing and maintaining adherence to pharmaceutical and / or nutritional supplement GLP / GMP is strongly desired.
• Effective interpersonal skills and the ability to interact with all levels of personnel are required.
• Demonstrated problem-solving skills.
• Excellent motivational and cross-functional team building skills.

Education and Experience : BS Degree in Chemistry, Microbiology or BA Degree in a related Science field is required. Minimum of 10 years' experience in Quality Control and Assurance in the nutritional supplement and / or pharmaceutical products manufacturing industry. Laboratory management experience is required to be considered for this role

Supervisory Responsibilities : Yes Quality Staff