Senior Compliance Validation Consultant

Client: Cipla USA - https://usa.cipla.com

Project Duration: Initial - 6 months

Location: Onsite: Fall River Massachusetts (near Providence RI) - Some remote work possible at times.

Hours / week: 40 hours / week

Start Date: Estimated April 14th or 21st, 2025 (Depending on equipment delivery / installation)

Interview Process: 1-2 hour in depth video interview with Head of Pilot Plant / R&D Ops

This role is related to the opening of new Cipla manufacturing plant currently nearing completion.

POSITION SUMMARY:

The Validation Compliance Consultant supports commissioning and qualification activities associated with cGMP equipment acquisition, installation, operation, and facility modification. The Validation Compliance Consultant will lead verification activities in alignment with Cipla Validation Master Plan to ensure that all cGMP equipment is installed and maintained in a qualified state. The Validation Compliance Consultant works in partnership with the Engineering management, Engineering Staff (Engineers and Technicians), Quality Assurance, and Equipment System Owners to develop and oversee the commissioning and qualification and validation strategy for equipment and processes.

• Responsible for overall supervision and oversight during execution of validation activities
• Develops, writes, and executes protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Supports periodic review of manufacturing systems to ensure that equipment remains in a qualified state and that processes remain in a validated state.
• Assists in all aspects of Process Validation including providing process risk assessments and authoring, writing, and reviewing validation protocols and reports.
• Leads Continuous Process Verification activities to ensure processes remain in a validated state.
• Assists with all aspects of Cleaning Validation from start to finish, including establishing, managing, and maintaining a scientifically sound cleaning validation program.
• Write reviews and execute cleaning validation protocols for product manufacturing and support processes, including analysis and review of test data results.
• Assists in summarizing results and conclusions when writing final reports.
• Ensure final reports and study data are reviewed and approved in a timely manner after execution is completed.
• Experience in a pharmaceutical manufacturing environment highly desired
• Strong organizational, prioritization, planning, and time management skills.
• Effectively communicate ideas using written and verbal means at all levels of management and across diverse functional teams.
• Ability to work in clean room environment.
• Ability to work effectively in a fast-paced and rapidly changing environment.