Mastech Digital
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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. Seniority level : Mid-Senior level Employment type : Full-time Industries : Engineering Services and Pharmaceutical Manufacturing Thanks Ritika Aithmian
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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. Seniority level : Mid-Senior level Employment type : Full-time Industries : Engineering Services and Pharmaceutical Manufacturing Thanks Ritika Aithmian
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