Product quality & safety assurance occupations Work, Jobs in Chalgrove, Oxf (with Salaries)

Quality Assurance Officer I
Replimune —Abingdon
- Full-time
- Microsoft Office
- Master's degree
- Bachelor's degree
Quick apply
11d
Quality Associate II, Quality Assurance
Replimune —Abingdon
- Full-time
- Microsoft Office
- Master's degree
- Bachelor's degree
Quick apply
11d
Quality Assurance Officer II
Replimune —Abingdon
- Full-time
- Microsoft Office
- Master's degree
- Bachelor's degree
Quick apply
11d
Quality Assurance Engineer
MDA Space —Didcot
- Hybrid work
- Engineering
- Analysis skills
- Bachelor's degree
- Employee assistance programme
- Life insurance
Quality Engineer (Medical Devices)
Amber Therapeutics —Didcot
- Full-time
- Hybrid work
- Engineering
- Quality control
- Communication skills
Quick apply
QA Coordinator (12 months fixed term contract)
Bio-Techne —Abingdon
- £34,400 - £55,120 a year
- Full-time
- English
- Bachelor's degree
- Business
- Employee stock purchase plan
4d
Pyro Inspector
Martin-Baker —Chalgrove
- Data analysis skills
- Annual leave
Quality Assurance Technical Officer
University of Oxford —Oxford
- £39,424 - £51,983 a year
- Full-time
- Laboratory experience
10d
Associate Quality and Systems Manager – (Asbestos, Fire & Water)
Tetra Tech —Abingdon
- Hybrid work
- Travel
- Leadership
SVP Regulatory Affairs & Quality Assurance
PrecisionLife Ltd —Oxford
- £85,000 - £105,000 a year
- Full-time
- Hybrid work
- Doctoral degree
- Computer Science
- Engineering
- Free parking
- Annual leave
Quick apply
1d
Quality Assurance Engineer
MDA —Didcot
- Full-time
- Hybrid work
- Engineering
- Analysis skills
- Bachelor's degree
- Employee assistance programme
- Life insurance
Product Assurance Specialist
UK Research and Innovation (UKRI) —Harwell
- £58,346 a year
- Full-time
- Travel
- Employee discount
- Flexible schedule
8d
Quality Assurance Regulatory Affairs Coordinator
Perspectum —Oxford
- £30,000 - £40,000 a year
- Full-time
- Microsoft Office
- IT
Quick apply
Operations Scientist - Analytical Method Validation
Abbott Laboratories —Witney
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Engineering
11d
QA Releaser
Baxter —Oxford
- Full-time
- English
- Microsoft Office
- Time management
- Annual leave
Quality Control Process Technician
Elements Solutions Inc —Wantage
- Microsoft Excel
- Quality control
- IT
- Free parking
PV Systems and Processes Lead x2
CSL Seqirus —Maidenhead
- Full-time
- No degree
- Leadership
- Communication skills
Senior Product Assurance Manager
Astroscale —Didcot
- £60,000 - £94,000 a year
- Full-time
- Hybrid work
- English
- Presentation skills
- Travel
- Life insurance
- Sick pay
GLP/GCLP Vendor Oversight and QA Lead (EU)
CSL Seqirus —Maidenhead
- Full-time
- Analysis skills
- Bachelor's degree
- Organisational skills
Head, PV and Regulatory QA
CSL Seqirus —Maidenhead
- Full-time
- Customer service
- Bachelor's degree
- Organisational skills

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product quality & safety assurance occupations jobs near chalgrove, oxf

Quality Assurance Officer I

Replimune -
Abingdon

Quick apply

Job details

Full-time
11 days ago

Qualifications

Microsoft Office
Master's degree
Bachelor's degree
IT
Root cause analysis
Communication skills
Time management

Full job description

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

The Quality Assurance Officer I provides guidance and coordination in the development, implementation and maintenance of Quality Assurance systems and activities at Replimune. Manages batch review to ensure timely release of drug product for clinical and commercial use. Ensures relevant quality and regulatory requirements are met for manufacturing and testing and ensures site compliance with quality system regulations issued by MHRA, EMA, FDA and other applicable regulatory bodies. Responsible for the evaluation and assurance that appropriate quality systems are in place at approved vendors and suppliers supporting GXP.

This position is based in our Milton Park location and typically has a 5-day on-site expectation.

Key responsibilities:

Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness. Provide QA input and approvals to assist in and drive projects as needed.
Perform batch review for GMP lots, in support of Qualified Person release including final Quality Review of associated quality records. Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.
Drive improvement of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
Possess strong writing skills to utilize best practices in documenting deviations in records and associated reports.
Collect and report quality metrics supporting Quality Management Review (QMR) deliverables.
Review and approve Standard Operating Procedures (SOPs), Validation Protocols / Reports, GMP records, Testing Records and other records generated by the site ensuring internal and external standards are met.
Interface and provide support to internal customers.
Lead and participate in Risk assessments.
Conduct trainings as needed (change control, batch release, risk assessment methodology, etc.).
Conduct routine compliance oversight activities e.g. facility/laboratory walkarounds.
Take part in Replimune internal and external audit program. Lead and direct audits of GMP materials and service providers.
Interface with internal customers in Product Development, Quality Control Labs, etc., and, as appropriate, with external vendors to support ongoing compliance with Replimune requirements and quality standards.
Ability to prepare slides and provide training to staff in applicable procedures.
Prepare and issue controlled logbooks for internal customers.
Archive and retrieval of documentation.

Other responsibilities

Support Replimune QA activities.
Drafts, reviews, provides oversight to content, and approves controlled documents which may include but are not limited to standard operating procedures, validation documents, material specifications, etc.
Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to support Replimune Clinical and Commercial operations.
Other duties as assigned.

Educational requirements:

A minimum of a bachelor’s degree (BSc or equivalent).
Masters preferred.

Experience and skill requirement:

4 years’ experience in relevant Quality Systems, technology and/or supervision in a regulated biotechnology or pharmaceutical industry environment.
GxP experience, including auditing.
Knowledge of MHRA, EMA and MHRA guidelines regarding GMPs.
Excellent verbal and written communication skills to interact with other functions.
High level of attention to details and excellent time management.
IT skills – competent in using Microsoft Office.
An interest in pharmaceutical Quality Assurance.
A level of flexibility is essential to meet varying workloads.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.

Quick apply

Refine Your Search

product quality & safety assurance occupations jobs in chalgrove, oxf

Quality Assurance Officer I

Quality Associate II, Quality Assurance

Quality Assurance Officer II

Quality Assurance Engineer

Quality Engineer (Medical Devices)

QA Coordinator (12 months fixed term contract)

Pyro Inspector

Quality Assurance Technical Officer

Associate Quality and Systems Manager – (Asbestos, Fire & Water)

SVP Regulatory Affairs & Quality Assurance

Quality Assurance Engineer

Product Assurance Specialist

Quality Assurance Regulatory Affairs Coordinator

Operations Scientist - Analytical Method Validation

QA Releaser

Quality Control Process Technician

PV Systems and Processes Lead x2

Senior Product Assurance Manager

GLP/GCLP Vendor Oversight and QA Lead (EU)

Head, PV and Regulatory QA

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