Senior Quality Operations Specialist at Thermo Fisher Scientific

Singapore

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, ManufacturingIndustries

Requirements

Bachelor’s Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a Pharma-related Scientific Area
4-6 years of relevant Quality experience in Pharmaceuticals/Biopharmaceuticals
Experience in Quality Management Systems, quality operations, and biologics/aseptic training is an asset

Responsibilities

Follow site safety requirements and maintain a safe working condition during daily operations
Provide shop floor QA supervision and problem-solving support to manufacturing operations, ensuring routine compliance
Perform Quality Monitoring for aseptic manufacturing processes and Acceptable Quality Checks for sterile products
Coordinate quality in microbiology, including vial reading for incubated media-filled vials
Support QC area by reviewing QC documents and participating in operational readiness programs
Assist QA manager with batch disposition and review validation documents, including computer system validation
Assess incoming materials for new product introductions and write operational procedures, reviewing all SOPs
Collect and analyze shop floor information, working with operations to resolve issues as a QA representative
Review and approve Master Batch Records and Master Formulation Records, ensuring compliance with TFS standards and cGMP requirements
Ensure all-time readiness for GMP and client audits, participating in deviation and OOS investigations
Lead root cause analysis with effective CAPA and support process validation, clean validation review, and approval
Establish and improve QA Operations procedures to enhance quality and efficiency continuously
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 are being accurately and efficiently handled
Involved in deviation and OOS investigation as quality representative
Participate in site operational readiness programmes like self-inspection, data integrity surveillance, fit and finish program
Implement emergency procedures and safe systems of work compliance
Adhere to environment, health, and safety rules, reporting and investigating all accidents, near misses, and rule breaches promptly

Skills

Key technologies and capabilities for this role

GMPcGMPAseptic ManufacturingQuality MonitoringBatch DispositionSOP WritingValidationMicrobiologyQC ReviewAudit ReadinessMaster Batch Records

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time role.

What is the work schedule and location setup for this role?

The position involves 12-hour shifts on days in a cleanroom environment with strict GMP safety standards, such as no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed. No remote work option is mentioned.

What key skills and experiences are required for the Senior Quality Operations Specialist role?

Key requirements include knowledge of GMP compliance, experience in aseptic manufacturing processes, quality monitoring, root cause analysis, CAPA, deviation and OOS investigations, SOP writing, and batch record review.

What is the team structure and mentorship like at Thermo Fisher Scientific for this position?

You will work under the mentorship of the QA Manager within a dedicated team focused on quality operations across shop floor, engineering, and warehouse.

What makes a strong candidate for this Senior Quality Operations Specialist position?

Strong candidates have expertise in GMP compliance, aseptic processes, quality monitoring, root cause analysis, CAPA implementation, audit readiness, and experience supporting manufacturing operations with problem-solving and document review.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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