QA & Validation Lead - Pharmaceuticals Job at ProStaff Solutions Inc
ProStaff Workforce Solutions is seeking a
Quality Assurance & Validation
Lead for one of the largest pharmaceutical companies in Billerica, MA. Our client is one of the leading pharmaceutical companies in the region and specializes in the production and sale of radiopharmaceuticals and formulation, analytical methods development and production of parenteral drugs. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
Full Time Onsite
Direct Hire
Job Description:
Responsible for providing Quality Assurance on floor support to Manufacturing Operations relative to the production of commercial and/or clinical products. Responsible for providing quality and technical support for commissioning, qualification and validation activities related to manufacturing equipment, processes, and utilities. Will support and facilitate the development and review of project plans, qualification protocols and reports for all stages of the qualification process, maintaining quality standards aligned with US FDA cGMP, QSR, ICH and other applicable international regulations and guidance documents.
Qualifications:
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
#IND1
#ps
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
Full Time Onsite
Direct Hire
Job Description:
Responsible for providing Quality Assurance on floor support to Manufacturing Operations relative to the production of commercial and/or clinical products. Responsible for providing quality and technical support for commissioning, qualification and validation activities related to manufacturing equipment, processes, and utilities. Will support and facilitate the development and review of project plans, qualification protocols and reports for all stages of the qualification process, maintaining quality standards aligned with US FDA cGMP, QSR, ICH and other applicable international regulations and guidance documents.
- Represent QA throughout the manufacturing process by providing compliance oversight and support to GMP operations.
- Ensure clean room aseptic behaviors are followed throughout the manufacturing process and personnel are trained in the job they perform.
- QA oversight of commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories.
- Qualification of various equipment, such as: utility equipment, lyophilizer, environmental monitoring system, labelers, liquid ampoule filler/powder auger, serialization systems, vacuum chambers
- Assessment of equipment/instrument related change controls to assure proper impact assessment to develop and maintain a qualified/validated state.
- Review and assist in investigating deviations related to manufacturing, process, equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments.
- Review equipment/instrument validation, qualification, requalification protocols.
- Perform monthly compliance walkthroughs and help drive the closure of any observations.
- Assist with internal and external audits
Qualifications:
- B.A. or B.S. degree (preferably in Life Science)
- Minimum of six (6) years of experience in the pharmaceutical, biopharmaceutical or related industry.
- Experience in the FDA regulated pharmaceutical or medical device industries
- Experience performing inspections and investigations
- Experience with EDMS, Trackwise, LMS preferred.
- Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
- Demonstrated excellent communication: verbal, written and presentation skills.
- Demonstrated ability to interact effectively with peers, management, and cross functional teams.
- Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
- Must be flexible in terms of working hours to meet requirements of position
- Sound knowledge of pharmaceutical quality system requirements
- Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
- Skills to independently evaluate situations and propose potential solutions are essential.
- A self-starter with a hands-on approach and a can-do attitude.
- Ability to think strategically and to proactively identify issues in various aspects of the drug manufacturing process.
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
#IND1
#ps
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