Category

Description

Duties/Expectations of Role

Ensures all products manufactured in the facility and released to market are pure, safe, and effective and meet all established regulatory requirements.
Keeps current with new guidelines and FDA inspectional and scientific trends and adjust facility procedures appropriately.
Provides leadership developing and directing quality assurance and improvement initiatives for all company procedures or processes within the site and ensures ongoing compliance with local, national, and international standards and legislation.
Leads the preparation for regulatory inspections and audits and provides support to their execution and follow-up. Ensures that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs.
Organizes and hosts facility audits by customers, FDA, and HPRA including responding to corrective actions and/or observations as required.
Evaluates investigations regarding batch discrepancies, non-conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence. Determines final disposition of the batch using scientific justification.
Ensures the entire facility operates in conformance with all regulatory requirements. Monitors the facilities compliance on a regular basis and addresses any deficiencies identified.
Promotes and advocates quality achievement and performance improvement across the organization by integrating quality control tools into processes and supporting new product development.
Oversee the Quality Control and Microbiology Laboratory in support of raw material and component release, finished product release and stability testing. Assure that problems are appropriately and scientifically investigated in accordance with GMP and that regulatory reports are filed as needed.
Lead the site transfer process for CMO projects including execution of gap assessment, coordination of technical transfer activities, QA oversight of manufacturing activities and development of Quality Agreements. Primary liaison with customer for quality and manufacturing issues.
Oversee the Quality of R

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