Senior QA Specialist
Key Knowledge/ Skills and Competencies
- Ability to perform functions independently in accordance with cGMP guidelines.
- Strong written and oral communication skills required
- Good interpersonal skills required
- Ability to work effectively and meet challenging timelines in a fast –paced and high throughput environment
- Strong organizational skills, work ethics and respect for all customers.
- Ability to independently coordinate with cross-functional teams
- Ability to think strategically and tactically, balancing these as workload changes.
- Attention to detail
- Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
- Proven 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 role
- Experience with release of incoming materials and materials management
- Project management skills desirable
- Medical device experience a plus
- As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to operations at the Vertex 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, deviations, 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 and Quality Systems
- Provide production floor support and guidance on any manufacturing related issues for GMP Continuous and non-continuous product manufacturing.
- Review and approval of Manufacturing documents (as required)
- Responsible for raw material release, area clearance, line clearance and equipment release
- Provide QA support of change controls, GMP investigations and CAPAs (as required). Responsible for updating QA database to support generating performance metrics, trends.
- Participate in compliance walkthroughs and help drive the closure of any observations
- 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.
- Participate in inspection readiness and support activities (as necessary)
- Participate in process improvement initiatives (as necessary).
- 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
REQUIRED EDUCATION AND EXPERIENCE:
- Demonstrated success by independently coordinating with cross-functional teams
- Experience providing QA support and oversight of Material Management operations including incoming material release.
- Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
- cGMP’s and associated CMC regulatory considerations
- experience with continuous manufacturing a plus
- Experience with network based applications such as Oracle, TrackWise, VeeQMS
- Experience providing QA support and oversight of GMP manufacturing operation including batch release
- 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.