Quality Assurance Team Leader

About this opportunity :

 

The position is responsible for documenting and auditing cGMP practices for the site and for leading a group of Quality Assurance Specialists.  The position develops and revises QA procedures to strengthen cGMP compliance as per the USFDA Title 21 Code of Federal Regulation Part 210, 211 and ICHQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.  The Quality Assurance Team Leader supports validation activities to ensure compliance with regulation and Avecia’s validation plan.

 

Key Responsibilities:

 

• Act as QA project representative on Manufacturing campaigns.
• 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.
• Act as lead auditor during vendor/internal quality audits to ensure that cGMP compliance is at the required standard for API manufacture, in accordance with ICH Q7 Guidance and FDA 21 CFR requirements.
• To support validation activities by providing input on the review and approval of validation protocols/reports and ensure that these documents/records comply with FDA validation guidelines and Avecia’s validation master plan
• Responsible for reviewing quality records.
• Responsible for writing/revising Quality Assurance procedures to strengthen compliance with cGMPs.  Reviewing and approving deviations and gathering/issuing quality metric reports to executive management.
• Provide strong link/communication between the QA function/activities with all other departments at the Milford site.
• Manage the Corrective and Preventative Action program.  This may include chairing the Material Review Board and conducting QA investigations as per the internal procedures.
• Conduct customer complaint investigations, as needed, and follow up with customers on all technical complaints until closure/resolution is reached.
• Provide assistance during cGMP compliance inspections of the Milford facility.  This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections.
• Strong attention to detail and self-checking skills.

 

Required Skills/Abilities:

 

The job requires a BS/BA in science or equivalent work experience with 5+ years’ experience in either Production or Quality Assurance.

 

The Quality Assurance Team Leader must be able to provide expert advice and sound decision-making on all aspects of cGMP.  He/she must have a strong knowledge of the cGMP regulation and technical knowledge of the subject and the potential issues involved.  This is achieved through a combination of experience in Quality Systems coupled with education and training in Quality Systems, cGMP, Quality audits, documentation, change control, corrective and preventative action, validation, calibration, review of quality records, quality metrics, failure investigations and manufacturing and laboratory controls as per cGMPs.  As the regulatory and cGMP requirements frequently change, the jobholder must also maintain current knowledge.