Job Description
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