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The Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. The Quality Specialist demonstrates high level of involvement in continuous improvement of quality assurance philosophy and practices ensuring alignment with all regulatory requirements.
As part of the Quality Operations and Compliance group primarily responsible with providing quality oversight and support to operations at the Vertex Drug Product Facility (VMC) in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management.
Product Release Internal Manufacturing
Responsible for commercial and clinical batch disposition. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
Responsible for approval of clinical and commercial lot COAs, generating BSE/TSE statement and product labelling
Responsible for archival of batch records and other supporting documents in QDoCCs.
Responsible for generating performance metrics, trends
Compliance Oversight of Internal Operations QA Operations and Compliance
Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
Review and approval of Manufacturing documents e.g. MCR, MBR, Recipe, Engineering Parameters etc.
Responsible for raw material release, area clearance, line clearance and equipment release.
May be required to assist the QA Engineering group with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
Compliance Oversight of Quality Systems
Provide QA support of development and commercial change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Lead the investigation/CAPA triage meetings (as necessary) and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
Responsible for generating performance metrics, trends; including site metrics for investigation/CAPA, etc.
Lead compliance walkthroughs of the site and help drive the closure of any observations.
Quality Process and Ownership of Equipment, Area, and Incoming Material Release
Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
Participate in continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.
Establishing or Tech Transfer of Products
Responsible for supporting new product introduction into the Drug Product Facility by review and approval of new MBRs and material master files.
Audit / Inspection Support
Participate in inspection readiness activities and provide support during regulatory site inspections (as necessary).
Deployment of QMS and Establishment of Compliance Expectations
Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.
Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner.
Master s degree with 2-3 years of relevant work experience, or Bachelor s degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background
Demonstrated success independently leading cross-functional teams
Experience providing QA support and oversight of GMP manufacturing operation including batch release
Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting: o cGMP s and associated CMC regulatory considerations
Experience with equipment, facilities and utility system qualifications activities in a cGMP setting
Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
Experience with network based applications such as Oracle and TrackWise preferred.
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