QA Validation Consultant

Location: Norwood, MA

Long term Contract

Job description of the role:

• Responsible for managing the Quality review/approval of design and commissioning documentation, validation protocols (including associated discrepancies), reports and/or support records to ensure compliance with industry standards and regulations as well as internal specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues
• Support review and approval of validation lifecycle documentation; including but not limited to: IA, URS, DQ, ERES, CDS/FRS, FMECA, IOQ
• Reviews and assists in investigating discrepancies/deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments
• Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method, and computer system validation
• Participates in cross functional meetings for planning and discussing changes to be commissioned, qualified, validated equipment/facilities/utilities
• Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs
• Use critical thinking skills to partner with CQV and facility engineers to problem solve
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Thanks

Ritika Aithmian

Lead Recruiter