Senior Quality Assurance Engineer

Senior Quality Assurance Engineer

Posted 5 days ago by LanceSoft UK

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Negotiable
Undetermined
Onsite
Slough, England, United Kingdom
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External Auditing Project Schedules Raw Data Verification And Validation

Summary: The Associate Principal QA Specialist role in Slough, UK, involves overseeing quality assurance activities, ensuring compliance with GMP standards, and providing support for various QA processes. The position requires a strong focus on continuous improvement and mentorship within the organization. The role is on-site and is structured as a 12-month contract.

Key Responsibilities:

  • Define specific short & long-term work duties starting with the most frequent and impactful.
  • Provide shoulder-to-shoulder review, approval and support for deviations, CAPAs, change controls, investigations and OOS records.
  • Review QA activities for MSAT studies, pilot studies, and Development Services.
  • Review QC activities including method validation, reference standards and stability studies.
  • Manage and escalate critical compliance issues through the QMS.
  • Conduct audit trail reviews.
  • Perform area walkthroughs to identify and resolve non-compliance.
  • Audit raw data, protocols and validation reports for GMP compliance.
  • Maintain and promote audit readiness.
  • Ensure protocols and validation reports are approved according to project schedules.
  • Lead process audits and support GMP audit activities.
  • Identify and participate in continuous improvement initiatives.
  • Support quality governance via Local Quality Councils and project meetings.
  • Provide QA SME support for Operations, QC, MSAT and Development Services.
  • Mentor and coach business partners in GMP practices.
  • Advise scientists on documentation and follow-up expectations.
  • Provide out-of-hours QA support where required.
  • Act as a GMP SME enforcing site quality processes.
  • Perform additional duties as assigned.

Key Skills:

  • Excellent decision-making and problem-solving skills.
  • Strong Quality mindset.
  • Strong business and interpersonal skills.
  • Persuasive communicator in written, oral and active listening.
  • Strong Continuous Improvement mindset.
  • Excellent communication skills (verbal and written).
  • Ability to meet strict deadlines.
  • Excellent organizational and planning skills.
  • Level Advanced - 5-10 years.

Salary (Rate): undetermined

City: Slough

Country: United Kingdom

Working Arrangements: on-site

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

Job Title: Associate Principal QA Specialist

Location: Slough, UK (Onsite)

Duration: 12 months contract

Job Description

Key Responsibilities

  • Define specific short & long-term work duties starting with the most frequent and impactful
  • Provide shoulder-to-shoulder review, approval and support for deviations, CAPAs, change controls, investigations and OOS records.
  • Review QA activities for MSAT studies, pilot studies, and Development Services.
  • Review QC activities including method validation, reference standards and stability studies.
  • Manage and escalate critical compliance issues through the QMS.
  • Conduct audit trail reviews.
  • Perform area walkthroughs to identify and resolve non-compliance.
  • Audit raw data, protocols and validation reports for GMP compliance.
  • Maintain and promote audit readiness.
  • Ensure protocols and validation reports are approved according to project schedules.
  • Lead process audits and support GMP audit activities.
  • Identify and participate in continuous improvement initiatives.
  • Support quality governance via Local Quality Councils and project meetings.
  • Provide QA SME support for Operations, QC, MSAT and Development Services.
  • Mentor and coach business partners in GMP practices.
  • Advise scientists on documentation and follow-up expectations.
  • Provide out-of-hours QA support where required.
  • Act as a GMP SME enforcing site quality processes.
  • Perform additional duties as assigned.

Required Skills & Competencies* e.g. technical, interpersonal, problem solving

  • Excellent decision-making and problem-solving skills.
  • Strong Quality mindset
  • Strong business and interpersonal skills and be a persuasive communicator in written, oral and active listening to influence peers and colleagues.
  • Strong Continuous Improvement mindset
  • Excellent communication skills (verbal and written).
  • Ability to meet strict deadlines.
  • Excellent organizational and planning skills.
  • Level Advanced - 5-10 years
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