Job Description
Title: Associate Principal QA Specialist, QA Technical Operations
Company: Global Pharmaceutical Manufacturing Organisation
Location: Slough, UK - Hybrid
Role Purpose:
* Support Operations to ensure compliance with GMP (Good Manufacturing Practice).
* Manage and address GMP issues through QMS processes, site governance, and senior QA leadership.
* Serve as a GMP subject matter expert (SME), implementing, managing, and enforcing quality processes on-site.
* Assist Senior QA leadership in driving continuous improvement and ensuring ‘fitness for purpose’, maintaining compliance with regulatory authorities, global quality standards, and customer expectations.
Key Responsibilities:
* Provide hands-on review, approval, and support to key business partners for managing quality records, including Deviations, CAPAs, Change Controls, Investigations, and OOSs.
* Apply knowledge of GMP and quality processes within functional areas to manage and escalate significant compliance issues through the site QMS processes, including deviations and CAPAs.
* Proactively identify, suggest, and participate in continuous improvement activities.
* Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment and quality culture.
* Ensure and promote audit readiness.
* Actively contribute to PQS process improvement initiatives and projects.
* Provide QA SME support at departmental Local Quality Councils and project meetings.
* Provide QA SME support for manufacturing during out-of-hours.
* Perform other duties as assigned.
Required Skills:
* Previous experience as a QA approver of Deviations, CAPAs, Change Controls, OOSs
* Scientific Degree Required
* Excellent decision-making and problem-solving abilities.
* Strong quality-focused mindset.
* Strong business and interpersonal skills, with the ability to communicate persuasively in both written and oral forms and actively listen to influence peers and colleagues.
Interested? Apply now for immediate consideration or contact Maria Tsalpatourou at mtsalpatourou@planet-pharma.co.uk
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