Quality Operations specialist at Thermo Fisher Scientific

Singapore

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelor’s Degree in Life Sciences, Chemical/Biochemical Engineering, or a related scientific area with equivalent experience
1-3 years of relevant quality experience in pharmaceuticals preferred (fresh graduates with relevant qualifications may also be considered)
Experience in Quality Management Systems and biologics is an asset
Knowledge of cGMP, Regulatory Compliance, and GMP Quality Management Systems
Strong detailed thinking and communication skills
Effective coordination and collaboration abilities
Proven problem-solving skills and knowledge of Quality Risk Management tools

Responsibilities

Follow site safety requirements and maintain safe working conditions during daily operations
Perform quality on the floor as shop floor QA performer and problem solver
Write all quality operational procedures and review SOPs from other functional teams
Provide QA support to manufacturing operations and coordinate routine shop floor compliance
Collect firsthand shop floor information and collaborate with operations teams to solve problems
Perform Quality Monitoring for aseptic manufacturing steps
Conduct Acceptable Quality Checks for sterile products
Coordinate microbiology quality for vial reading of incubated media-filled vials
Support QC area by reviewing QC documents
Participate in site operational readiness programs, including self-inspection and data integrity surveillance
Review and approve Master Batch Records and Master Formulation Records to ensure compliance with TFS quality standards and cGMP requirements
Assist QA manager with batch disposition
Review and approve validation documents, including computer system validation
Maintain site readiness for GMP and client audits
Lead or participate in deviation and OOS investigations to determine root causes and implement effective CAPAs
Review and approve relevant procedures to ensure compliance with cGMP and TFS quality standards
Support regulatory inspections and client audits to ensure effective management of QA operations areas

Skills

Key technologies and capabilities for this role

GMPcGMPSOPQACAPAOOSAseptic ManufacturingMicrobiologyBatch RecordsValidationDeviation Investigations

Questions & Answers

Common questions about this position

What education and experience are required for this Quality Operations Specialist role?

A Bachelor’s Degree in Life Sciences, Chemical/Biochemical Engineering, or a related scientific area is required, along with 1-3 years of relevant quality experience in pharmaceuticals preferred; fresh graduates with relevant qualifications may also be considered.

What key skills are needed for this position?

Candidates need knowledge of cGMP, Regulatory Compliance, and GMP Quality Management Systems, strong detailed thinking and communication skills, effective coordination and collaboration abilities, and proven problem-solving skills with knowledge of Quality Risk Management tools.

Is this a remote position, or what is the work schedule?

This is a full-time position with a 12 hr shift/days schedule in an office or manufacturing environment adhering to GMP safety standards; remote work is not indicated.

What is the salary or compensation for this role?

This information is not specified in the job description.

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

Strong candidates will have a Bachelor’s Degree in a relevant scientific field, 1-3 years of pharmaceutical quality experience or relevant qualifications as a fresh graduate, and proficiencies in cGMP, problem-solving, communication, and collaboration; experience in Quality Management Systems and biologics is an asset.

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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