QA Specialist II - Validation, cGMPs, Engineering, Commissioning

Company: Yoh, A Day & Zimmermann Company
Location: Manchester
Posted on: January 10, 2021

Job Description:

Sr. QA Specialist, Validation (Biologics, cGMP, CAPAs, Commissioning) Sr. QA Specialist II - Validation, is a member of the Quality Assurance (QA) department and is responsible for providing quality support for the Validation units across all three sites by reviewing/approving GMP engineering and validation documentation. Additionally, provides compliance support of Quality Systems including; Deviations, CAPAs, and Change Controls which are associated with validated systems. Provides sound scientific and compliance expert input during the development, review and approval of cGMP Validation documentation; i.e. protocols, reports, SOPs, etc. REQUIRMENTS10-15 years of Validation and/or Quality Assurance experience in the pharmaceutical industry, BS or BA in a Science or Engineering discipline. 15+ years relevant experience with a High School diploma 5-10 years of relevant experience and a MS Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards Deeply Experience in providing oversight in implementing and maintaining GMP equipment, processes and computer systems in a validated state Expertise with in Validation Methodology, Software Development Life Cycle (SDLC) principles and Part 11 Compliance Keen understanding of international quality systems regulations to adopt best in class systems/ processes and drive Continuous Improvement initiatives Demonstrates ability to perform detail-oriented work with a high degree of accuracy Excellent verbal, written and interpersonal communication skills Effective time management and interpersonal skills. The incumbent must be self-motivated, able to correctly set his/her own priorities for the multiple projects that will be simultaneously managed and meet project deadlines Strong organizational skills, planning skills and must work effectively within teams RESPONSIBILITIESProvide QA oversight for GMP Validation activities and apply risk based methodology to Validation efforts. Review and approve protocols and reports, associated with the Commissioning and Validation of equipment and utilities, Cleaning Validation, Process Validation and Method Validations without supervision. Provide QA assessment and approval of GMP validated systems related procedures, deviations, CAPAs and change controls with no supervision depending on complexity of system. Continuous improvement and development of Quality Systems to ensure quality and adherence to cGMPs. May support cGMP manufacturing operations as needed with review of batch records and supporting documentation (Deviations, Investigations, Environmental Monitoring, and Sterilization records). Works closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements across all sites. Provides guidance/mentoring to junior members of QA team on less complex issues #ZipSPG

Keywords: Yoh, A Day & Zimmermann Company, Manchester , QA Specialist II - Validation, cGMPs, Engineering, Commissioning, Engineering , Manchester, New Hampshire