Senior Quality Operation Specialist

Senior Quality Operation Specialist

Thermo Fisher Scientific
5-8 years
Not Specified

Job Description


Job Description :

JOB SUMMARY:
Drug Products (DP) operational quality assurance to ensure cGMP and regulatory compliance with respect for the defined methods, current regulations, and corporate quality standards. It mainly covers but not limited to:

  • DP shop floor QA supervision and problem solving

  • Master Batch record and Master Formulation record quality review

  • Raw materials, components, DP finished goods specification review and quality disposition

  • Deviation management and investigation/OOS quality involvement and approval

  • Process Equipment C&Q related documents Quality review and approval

  • Process validation and clean validation quality review and approval

Shift work schedule will be required in 2023*

RESPONSIBILITIES:

  • Follow site safety requirements and maintain safe working conditions during daily operations

  • DP shop floor QA supervision and problem solving

  • Responsible for providing QA support to manufacturing operations and Oversee DP shop floor routine compliance to ensure compliant execution

  • Collect shop floor firsthand information and work with operations team to do problem solving as QA representative

  • Perform Master Batch record and master formulation record quality review in a timely manner to ensure MBR and MFR meet TFS quality standard and cGMP requirements

  • Review Raw materials, components, BDS specification to ensure compliant to applicable regulations and do quality disposition for Raw materials and components according to pre-approved specifications.

  • Involved in deviation and OOS investigation as quality representative:

  • Establish and maintain deviation management system, provide insight and periodical trending analysis of deviations

  • Lead/participate site deviation and OOS investigation to ensure root cause analysis with effective CAPA

  • Responsible for Process Equipment C&Q related documents Quality review and approval to ensure compliant C&Q execution and document deliverables

  • Involved in Process validation and clean validation quality review and approval to ensure compliant validation output

  • Perform quality review and approval for relevant procedures to ensure procedures meet cGMP and TFS quality standards requirements

  • Support the activities of gap analyses versus the GMP regulations updating and new guidelines requests

  • Prepare, review standard Operating procedure for the site

  • Support the site Regulatory Inspections and client audit to assure that QA Operations related areas of each inspection is properly and effectively managed

  • Participates in the QA support to internal manufacturing and technical groups, and specific projects within functional areas for different clients

  • Establish procedures of QA Operations and continually seek ways to improve procedures to enable continuous enhance of the quality and efficiency of work performed by QA Operations

  • Other appropriate job-related activities assigned by organization

REQUIREMENTS:
Education:

  • Bachelor's Degree in Life Sciences or Chemical/Biochemical engineering, Pharma related Scientific Area

Experience:

  • At least 5 years QA experience in Biologics and Pharma Operations

  • Experience in Quality Units of Biologics pharmaceutical company with sterile production

Competencies:

  • Practical knowledge in PIC(s)/NMPA/FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals

  • Technical knowledge of (bio)pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable

  • Communicates honestly and effectively with subordinates, peers, manager, senior leaders, and customers

  • Problem solving, appropriately finds problems and follows protocol to implement creative solutions

  • Continuous improvement mindset

  • Conflict Management, resolve issues and escalates as needed

  • Able to work with the goals and objectives of the Site Quality and translate them into actionable work to meet those goals and objectives

  • Participates and/or leads meetings, provide input on timelines, potential compliance issues and other related QA activities

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