Senior Quality Assurance Engineer

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