Quality Specialist
This vacancy is published by an accredited employer with authorized corporate payroll and standard compliance adherence.
Transatlantic Cost of Living & Purchasing Power Benchmark
Position Overview & Specifications
- Align clinical study documentation to packaging product order output.
- Review and approve master batch records and executed batch records to assure compliance with procedural standards.
- Review and approve Clinical label content, including variable data approval.
- Render quality disposition of packaged supplies and supporting materials (e.g. labels, packaging component, comparator etc.) in current inventory system.
- Support Period of use / Expiry update of products.
- Independently solve error or issues presented during daily operations.
- Independently record verification checks performed in GMP documentation.
- Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Suggest improvements and conduct continuous improvement activities.
- Investigate, document Quality Assurance related deviations, investigation and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
- Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.
- Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
- Review, support and/or approval of validation documents, cleaning & method validation.
- Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.
- Educated to Degree level
- Demonstrable experience
- Experience in Quality systems
- Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
- Proactive approach and strong critical thinking skills
- Must be able to work in a team environment within own team and interdepartmental teams
- Excellent communication and interpersonal skills
- Good working knowledge of Microsoft Excel and Word
- Degree or Master's degree and relevant pharmaceutical experience
- Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
- Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure
Work Location Assignment: Flexible
Candidate Selection & Onboarding Process
Application & Resume Screening
Submit your tailored CV/Resume directly to the talent acquisition portal.
Technical & Competency Interviews
Virtual interviews with the hiring manager and multidisciplinary team.
Formal Offer & Benefits Negotiation
Written agreement outlining compensation, equity, retirement vesting, and relocation allowances.
Onboarding & Corporate Integration
Equipment provisioning, team orientation, and commencement of duties.
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Quality Specialist • Pfizer
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