Title:  Qualification, Validation, IPQA Lead

Date:  Jul 21, 2022
Location:  Billerica - Sun
Company:  Sun Pharmaceutical Industries, Inc (USA)

Job Summary:

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.
•    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. 
Environmental related to manufacturing/production environments:
•    Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
•    Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
•    Odors: Unpleasant smells.
•    Gases: Examples include carbon monoxide and ozone.
•    Dust: Airborne particles of any kind, such as textile dust, wood, and silica.


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

Travel Estimate    Up to 5%

Education and Job Qualifications:

•    B.S. degree (preferably in Life Science/Engineering).
•    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.



•    Minimum of ten (10) 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.