Quality assurance manager Work, Jobs in Swindon, Wil (with Salaries)

Senior Manager, Quality (Sterility Assurance)
Thermo Fisher Scientific —Swindon
- Full-time
- Bachelor's degree
- Continuous improvement
- Communication skills
Chief Inspector
iCOMAT —Swindon
- Overtime
- Analysis skills
- Continuous improvement
- Quality control
6d
Operations Quality Lab Team Leader
Abbott Laboratories —Witney
- Full-time
- Laboratory experience
- Continuous improvement
- Quality control
Quality Manager – Asbestos (6 month fixed term contract)
Tetra Tech —Abingdon
- Continuous improvement
- Quality control
- Mentoring
Electrical Quality Systems Team Leader
UK Atomic Energy Authority —Culham
- £57,117 a year
- Full-time
- Remote
- Engineering
- Continuous improvement
- Team management
- Annual leave
- Employee assistance programme

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Senior Manager, Quality (Sterility Assurance)

Thermo Fisher Scientific -
Swindon

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Job details

Full-time

Qualifications

Non-conformance investigation
Stakeholder collaboration
Internal department liaison
Quality management
Bachelor's degree
Continuous improvement
Environmental monitoring
Multidisciplinary collaboration
Pharmaceutical industry setting experience
Aseptic technique
Quality management system (QMS) implementation
Communication skills
Internal audits
FDA regulations

Full job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Position Summary:

The Senior Manater, Quality (Sterility Assurance) at Thermofisher plays a critical role in ensuring that all GMP operations maintain the highest standards of contamination control, sterility assurance and microbiological excellence. This position is a collaborative role, working with fellow CCME global team members, Operations, MSAT, Engineering and quality colleagues.

The role is responsible for the definition and implementation of site sterility assurance policies and procedures, in alignment with global policies and standards related to contamination control, sterility assurance and microbiology across all PSG sites to ensure alignment, standardization and compliance with current regulatory requirements.

Core Roles and Responsibilities

Site Support

Develop, implement, and maintain site contamination control strategies based on contamination control risk assessment in alignment with global quality procedures and EU GMP Annex 1, FDA 21 CFR, ISO and PIC/S.
Provide subject matter expertise (SME) in sterility assurance, microbiology, microbiological methods, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, cleaning and disinfection and other relevant areas required by site CCME and corporate quality management.
Support review of EM trends across the site and work with site teams to remediate adverse trends and maintain environmental control in all cleanrooms.
Provide site support and direction to complex deviations or laboratory investigations related to Microbiology, Contamination Control and Sterility Assurance. Where appropriate, support with CAPA plan definition, preventive measures and continuous improvement initiatives.
Provide site support for complex risk assessments related to Microbiology, Contamination Control and Sterility Assurance.
Own and implement the site APS strategy in alignment with the PSG APS strategy and collaborate with MSAT, validation and Operations to oversee compliant execution of each APS.
Provide guidance and coaching to Quality on the Floor in all sterility assurance matters to ensure maintenance of contamination controls during all operational activities.
Provide oversight and approval of Airflow Visualization studies and collaborate with MSAT, validation and operations in their execution.
Support development and implementation of the site intervention risk assessment and aseptic intervention strategy.
Provide guidance and support for training, coaching, oversight and monitoring of aseptic practices during all operational activities.
Act as process owner and implementation lead for the implementation of all global CCME procedures.
Provide guidance during facility and process design, including design led contamination controls and material/personnel and waste flows. Provide SME input into the qualification of manufacturing equipment and cleanroom that impact CCME including proper selection and validation of sterilization processes (e.g., autoclaves, SIP, filter integrity testing).

Inspection Readiness

Provide subject matter expertise during regulatory inspections and internal audits.
Ensure all GMP operations comply with global regulatory requirements (FDA, EMA, MHRA, WHO, etc.).
Participate in internal/corporate audits when required.
Contribute to inspection readiness programs by mentoring, coaching and challenging site based SMEs in CCME topics.
Review of inspection/audit observation responses

Leadership and Culture

Training and Personnel Qualification: Develop and deliver training programs on sterility assurance, aseptic practices, gowning, microbiology, and contamination control.
Process ownership of assigned quality system elements such as APS, EM, Cleaning and Disinfection or others as applicable.
Build and maintain strong relationships and collaborate effectively with all levels cross functionally within the organization. Facilitate continuous improvement and development of pragmatic compliant solutions to identified issues.
Promote a culture of contamination control awareness and quality excellence and use data trending (EM, utilities, deviations) to drive improvements in aseptic control.
Benchmark best industry practice through networking and attendance at key webinars, seminars, etc.
Role model the 4-I corporate values of Integrity, Intensity, Innovation and Involvement.
- Intensity – Honor commitments, communicate openly and demonstrate the highest ethical standards
- Intensity – Be determined to deliver results with speed, excellence and a passion to succeed
- Innovation – Create value by transforming knowledge and ideas into differentiated products and services for our customers
- Involvement – Make connections to work as one global team, embracing unique perspectives and treating others with dignity and respect

Required Qualifications:

Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or a related field.
5–10 years experience in supporting sterile/low bioburden pharmaceutical manufacturing and/or microbiology roles.
Strong understanding of aseptic manufacturing, cleanroom classification, disinfection, and contamination control.
Deep knowledge of GMP, Annex 1, FDA aseptic guidance
Understanding of barrier technologies (RABS, isolators) and their implementation
Effective communicator, able to influence and collaborate with cross-functional teams
Prior experience with regulatory inspections and audit defense.
Experience with CCS implementation preferred

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Refine Your Search

quality assurance manager jobs in swindon, wil

Senior Manager, Quality (Sterility Assurance)

Chief Inspector

Operations Quality Lab Team Leader

Quality Manager – Asbestos (6 month fixed term contract)

Electrical Quality Systems Team Leader

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