Thermo Fisher Scientific

Work Schedule

Rotational shift days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

The Quality Operation Specialist is responsible for the execution of quality compliance relevant activities that maintain GMP compliance in shopfloor, engineering and warehouse through appropriate vigilant and guidance from QA Manager, ensuring site compliance with GMP requirement and corporate policies and procedures is maintained.

This position will play an important role in QA team, to ensure adherence and effectiveness of site’s quality compliance, and identify opportunities for continues improvements of site quality system. This position will also ensure timely delivery of our commitment to Regulatory and Clients and work as an expert in Quality ops to ensure Quality Risks are identified and properly mitigated. Scope of work also includes other supporting activities from quality compliance perspective, to make sure site practices are meet cGMP and corporate requirements.

This role plays a major role in identifying near misses in manufacturing area to ensure product quality and patient’s safety.

Responsibilities

• Follow site safety requirements and maintain safe working condition during daily operations.
• Quality on the floor: shop floor QA performer and problem solving.
• Responsible for writing all quality operational procedures and reviewing all SOPs from other functional teams.
• Responsible for providing QA support to manufacturing operations and Oversee 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 Quality Monitoring for aseptic manufacturing steps.
• Perform Acceptable Quality Checks for sterile products.
• Quality Oversight in microbiology for vial reading for incubated media filled vials.
• Quality support in QC area for review of QC documents
• Participate in site operational readiness programmes like self-inspection, data integrity surveillance, fit and finish program. Incoming Material assessment for introduction of new product.
• Review and approve Master Batch record and master formulation record in a timely manner to ensure MBR and MFR meet TFS quality standard and cGMP requirements.
• Support QA manager for batch disposition
• Review and approve validation documents including computer system validation
• Review usage logbooks, GMP data on routine and non-routine basis to ensure compliance in shop floor documentation.
• Ensure site all time readiness of site for GMP and or client audits.
• 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.
• Ensure all time readiness of the site for regulatory audit.
• Support the site Regulatory Inspections and client audit to assure that QA Operations related areas of each inspection is properly and effectively managed.
• 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.
• Ensure compliance to upkeep site for all time readiness for regulatory and customer audit.
• Other appropriate job-related activities assigned by organization.
• Participate in hosting client and regulatory audit, responsible for timely and effective execution of external audit commitments. Interact with SMEs in all functional areas of the site to manage their response to any findings and their timely commitment to address those findings within CAPA and other quality systems.

EHS

• Understand and ensure implementation of emergency procedures and safe systems of work.
• Ensure compliance with environment, health and safety rules, signage, and instructions at all times.
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Minimum Requirements/Qualifications

Education:

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

Experience:

• 1 - 3 years of relevant Quality experience in pharmaceuticals preferred. Fresh graduate with relevant qualifications may also be considered.

Experience in Quality Management System, quality operation, Experience in biologics and aseptic training is an asset.

• Experience in site data integrity management is an asset.

Competencies:

• Knowledge in cGMP and Regulatory Compliance and GMP Quality Management System.
• Effective Systematical Thinking and Communication ability.
• Good Coordination and Collaboration.
• Effective execution and result driving.
• Good at problem solving and Quality Risk Management knowledge and tool.