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Qualification, Validation and IPQA Lead

Location: Billerica
Posted on: January 11, 2022

Job Description:

Job SummaryResponsible 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.
Area Of Responsibility

  • Represent QA throughout the manufacturing process by providing compliance oversight and support to GMP operations
  • Perform line clearances in manufacturing areas including labeling/packaging
  • Perform all IP QA related activities in manufacturing areas
  • Ensure cleanroom 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 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
    Work Conditions:
    • Corporate Office Environment located in a Manufacturing/Production and Warehouse Facility Physical Requirements:
      • 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

Keywords: SUN PHARMA, Billerica , Qualification, Validation and IPQA Lead, Other , Billerica, Massachusetts

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