Commissioning Qualification CQ Lead Pharmaceuticals Lebanon Indiana Contract Senior-level Hybrid
Commissioning Qualification CQ Lead Pharmaceuticals Lebanon Indiana Contract Senior-level Hybrid
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Job Description
Overview:
Fromdevelopment to commercialization we partner with Pharmaceutical MedicalDevice and Biotechnology clients to provide solutions to complex complianceissues. We collaborate with our partners by providing technical expertise inQuality Regulatory Compliance and Manufacturing Science and Technology. Ourbusiness mission is to ensure our clients exceed their compliance goals whileimproving patient health and safety. Visit us at and follow us on LinkedIn: Fortune500 Pharmaceutical client has an exciting opportunity for a Commissioning &Qualification (C&Q) Lead
Job Summary:
The C&Q Lead is responsible for managingthe entire Commissioning and Qualification (C&Q) process within GoodManufacturing Practice (GMP) regulated environments. This role requires a deepunderstanding of validation practices for equipment and systems along with theability to align crossfunctional project teams and support continuous processimprovement. The C&Q Lead will manage project deliverables guide the teamon validation practices and ensure adherence to regulatory standards includingFDA and GMP guidelines.
Responsibilitiesand Job Requirements:
Lead andexecute the C&Q process facilitating alignment sessions and supporting theimplementation of new processes.
Provide clearguidance on using C&Q templates drafting and updating critical C&Qplans such as the Project Validation Plan and Test Plan.
Track andresolve C&Q action items ensuring accurate documentation and compliance.
Offerexpertise on validation standards (e.g. GAMP ISPE ICH) and regulatoryrequirements including FDA regulations for medical devices and combinationproducts.
Overseedocument reviews and approvals monitoring C&Q progress and reportingmetrics to the IDM Engineering C&Q Manager.
Drivecontinuous improvement through process evaluations working closely withvarious project functions to maintain C&Q alignment.
Create astaffing model to support C&Q activities manage support staff andparticipate in essential project meetings.
Handleadministrative tasks including access requests for validation platforms likeKneat and engage in Design Review sessions and Site Acceptance Testing (SAT)activities.
MinimumQualifications:
10 years ofexperience as a Commissioning & Qualifications Lead in a Pharmaceuticalsetting.
BachelorsDegree or Advanced Degrees (Master of Science and PhD) related to Engineeringand Life Sciences.
Proficiencyin validation for equipment and computer systems within GMPregulated settingspreferably in the pharmaceutical industries.
Indepthknowledge of external validation standards (GAMP ISPE and ICH) and regulatoryrequirements particularly FDA standards for medical devices.
Exceptionalcommunication skills with the ability to guide team members and influencecrossfunctional stakeholders informally.
Demonstratedcapability to work independently in a complex network environment withinitiative and problemsolving skills.
Priorexperience with automated equipment validation and managing largecrossfunctional projects.
Strongunderstanding of how validation is impacted by modifications to equipment orsystems.
TravelRequirements: Ability to travel internationally and domestically to OriginalEquipment Manufacturers (OEMs) for design reviews Factory Acceptance Testing(FAT) and Site Acceptance Testing (SAT) including extended presence forentire review periods.
Other Details:
Schedule: 40hours per week
ContractLength: 12 months
Location:Lebanon Indiana
Setup:Hybrid
EEO Employer:
PharmaviseConsulting Corp. is an equal opportunity employer. We do not discriminate orallow discrimination on the basis of race color religion creed sex(including pregnancy childbirth breastfeeding or related medicalconditions) age sexual orientation gender identity national originancestry citizenship genetic information registered domestic partner statusmarital status disability status as a crime victim protected veteran statuspolitical affiliation union membership or any other characteristic protectedby law. Pharmavise Consulting Corp. will consider qualified applicants withcriminal histories in a manner consistent with the requirements of applicablelaw. If you have visited our website in search of information on employmentopportunities or to apply for a position and you require accommodation inusing our website for a search or application please contact .
Pharmavise Consulting Corp. is a regulatorycompliance consulting firm that partners with Pharmaceutical Medical Deviceand Biotechnology clients. When you join Pharmavise you become part of a teamthat values Excellence Through Quality.
EVerify Participation:
Pharmavise Consulting Corporation participatesin EVerify and will provide the federal government with your Form I9information to confirm that you are authorized to work in the U.S. If EVerifycannot confirm that you are authorized to work Pharmavise is required to giveyou written instructions and an opportunity to contact the Department of HomelandSecurity (DHS) or Social Security Administration (SSA) so you can begin toresolve the issue. For more information on EVerify please contact DHS ator through their website at dhs/everify.
Employment Type
Contract
