Lead Quality Auditor (387)

Equal Opportunity Employer

　

Purpose of the Position:

The position is responsible for documenting and auditing cGMP practices internally and externally as per the USFDA Title 21 Code of Federal Regulation Part 210, 211 and ICHQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. The Lead Quality Auditor supports Avecia's supplier management program to ensure compliance with regulations.

Key Job Responsibilities:

Act as lead auditor during internal and external quality audits to ensure that cGMP compliance is at the required standard for API manufacture, in accordance with ICH Q7 Guidance and FDA 21CFR requirements.

To play a key role in the cGMP compliance activities at the Milford site and continuously work with other departments to maintain and monitor compliance with cGMPs.

Develop, maintain, and execute the external audit schedule to support the vendor assurance program.

Develop, maintain, and support execution of the internal audit schedule.

Provide cGMP training to site staff as needed and ensures that there is full understanding of the Milford site Quality procedures

Responsible for writing/revising Quality Assurance procedures to strengthen compliance with cGMPs.

Review and approve quality records and gather/issue quality metric reports to executive management.

Key support of supplier management program, including qualification of vendors/materials, change management, and quality agreements.

Support supplier complaint investigations, as needed, and follow up with suppliers until closure/resolution is reached.

Provide strong link/communication between the QA function/activities with all other departments at the Milford site.

Provide assistance and expertise during cGMP compliance inspections of the Milford facility.

Provide expertise and guidance for implementing improvements within the quality system

Provide support for internal customer projects as needed

Job Knowledge Required:

Minimum of BS/BA in science or equivalent work experience

5+ years' experience as a Quality Assurance auditor in an FDA regulated biotechnology or pharmaceutical environment

Strong written and verbal communication skills

Strong interpersonal skills