Qualification and Validation Lead
29 Dunham Rd Billerica, MA 01821 US
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.
Area Of Responsibility
- 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 and 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 including IQ, OQ, PQ.
- Perform IT related activities including but not limited to production equipment and QC/ laboratory instrument.
- Perform monthly facility walkthroughs and help drive the closure of any observations and assure compliance
- Assist with internal and external audits.
- Other duties as assigned.
- B.S. degree (preferably in Life Science/Engineering) required
- 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
- Preferably knowledge of Trackwise (TW) to handle electronic Quality Manage System (eQMS) data, SAP, EDMS, LMS, Master Control etc.
- 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
- Five to ten years of experience in the pharmaceutical, biopharmaceutical, medical device or related industry
- Experience in the FDA regulated pharmaceutical or medical device industries
- Experience performing inspections and investigations
- Experience with EDMS, Trackwise, LMS preferred
- Corporate Office Environment located in a Manufacturing/Production and Warehouse Facility
- Position requires the ability to sit and/or stand for a minimum of 8 hours per day; use hands and fingers to handle or feel, walk, bend, reach, lift, talk and hear
- Close vision and ability to tell color differences/have normal color vision
- Lift up to 35 lbs.
- Must be able to wear safety glasses/goggles and other personal protection as required for entry and work in the manufacturing facilities
- Up to 5%
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.