Senior QA Officer Newcastle

Summary of Position

Ensure site compliance with the Specials guidelines, the current international pharmaceutical legislation and related guidelines, along with company requirements.

Support culture of excellence for the site.

Essential Functions

• Reviewing compliance of production and analytical methods with GMP/specials guidelines and EP, BP and/or SmPC
• Documentation management including review and update SOPs and forms
• Assist with deviations, incidents and investigations, OOS, CAPA, Change control and release of incoming materials
• Review QC tests and Micro results, managing Out of specification results
• Ensure timely completion and update of all Quality records and trackers
• Support the site to ensure it is GMP complaint by making sure SOPs are up to date
• Oversight, review and Approval of Validation Reports for all equipment in accordance to VMP
• Assist with all elements of the QMS including Deviations, Complaints, OOS, CAPA, Change Control, Recall, Micro Out of Specification, Risk Assessments and related trending
• Assist in Quality Management Review data and presentation. Participate in Batch review to aid Release for Shipment and prepare batch manufacturing records for QP review and release in accordance to licence
• Ensure batch records are reviewed in line with licence dossier
• Assist with inspection readiness
• Collaborating with Head of Quality in gathering necessary data and information for responses to regulatory inspection reports and assuring proposed actions are implemented and completed in a timely manner
• Coordinating internal self-inspections according to schedule
• Take part in Regulatory inspections if required
• Accurately perform Quality Control testing on all manufactured products at the LRP according to SmPC and EP guidelines
• Manage Environmental Monitoring process and ensure data are recorded and trended in the QMS
• Reading Microbiological plates, broth and sterility samples
• Interpretation and recording of Microbiological data and report any out of specifications ensuring appropriate action is taken in a timely manner
• Review and maintain QC logbooks and data to ensure the site meets all its objectives in relation to data integrity policy
• Assist with preparation of Quality assurance meetings
• Undertake activities as directed by Quality Management

Requirements

Level of professional and intellectual ability

• Knowledge of radiation (Desirable)
• Strategic thinker, able to see long term opportunities

Education/experience

• Educated to degree level in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology
• 2 Years Quality Systems Experience (Essential)
• Experience in the operation of GMP facilities (Essential)
• Sound knowledge of general management practices and business
• High technical aptitude as well as good communicative and interpersonal skills
• Stress handling
• Excellent and up to date working knowledge of current EU GMP