REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES Key Leadership Skills :
Cross- functional collaborator
Results DriverKey Knowledge / Skills and Competencies : oAbility to perform functions in accordance with cGMP guidelines.
oStrong written and oral communication skills requiredoGood interpersonal skills requiredoAbility to work effectively and meet challenging timelines in a fast paced and high throughput environmentoStrong organizational skills, work ethics and respect for all customers.
oCollaboration / Teamwork / Conflict ManagementoAbility to independently coordinate with cross-functional teamsoCritical ThinkingoAbility to think strategically and tactically, balancing these as workload changes.
oFlexibility / AdaptabilityoShould be flexible to work 2nd shift as per the business needsoKnowledge in the following areas : oExpert knowledge of global GMP requirements governing oral drug products and knowledge of oraldrug product manufacturing practicesoProven experience supporting GMP manufacturing either via experience in manufacturing and / or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical roleKEY RESPONSIBILITIES :
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 reviewing batch data, including batch records, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
Responsible for dispositioned product labelling and coordinating with Materials Management to support product shipment.
Responsible for archival of batch records and other supporting documents in QDoCCs.Compliance Oversight of Internal Operations QA Operations and Compliance
Responsible for raw material release and labelling
Responsible for CNC area clearance and equipment release to support manufacturing operations.Compliance Oversight of Quality Systems
Responsible for updating QA database based on the ongoing / upcoming clinical and commercial manufacturing.
Responsible for generating performance metrics, trends; including site metrics for investigation / CAPA, etc. (as applicable)
Responsible for identifying risks and communicating gaps for GMP process / systems.
Responsible for identifying risks and communicating any gaps for quality processes optimization for area / equipment release, material disposition, quality systems etc.Audit / Inspection Support
Participate in inspection readiness activities and provide support during regulatory site inspections (as necessary).REQUIRED EDUCATION AND EXPERIENCE :
Demonstrated success by independently collaborating with cross-functional teams
Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting : ocGMP’s and associated CMC regulatory considerationsoexperience with continuous manufacturing a plus
Experience with network based applications such as Oracle and TrackWise preferred.
B.S in scientific or allied health field (or equivalent degree) with at least 5 years of relevant work experience