Pinewood Healthcare is a leading developer, manufacturer and marketer of healthcare products, currently employing over 320 people across two sites in Tipperary and Dublin. Originally established in 1976 to serve the renal care market in Ireland, Pinewood evolved over the years under indigenous Irish ownership until its sale in 2006 to the Wockhardt Group, an Indian global pharmaceutical and biotechnology company headquartered in Mumbai, India. Wockhardt employs over 7,000 people across 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland (Pinewood Healthcare).Key areas of responsibility (include but not limited to):Originating, Approving and Issuing Production Documentation (Manufacturing & Packaging)Originating, Approving and Issuing Standard Operating Procedures (SOP's), in compliance with cGMP requirementsReviewing SOP's, as per review scheduleIssuing Stability Documentation, approval of testing protocols, review of stability reportsReviewing Validation protocols & validation reports (including process validation, cleaning validation and equipment validation protocols and reports)Reviewing Product Development DocumentscGMP trainingInternal and external auditingInvestigating and review of deviations and out of specification resultsInvestigating customer complaintsProofing and approval of artworkMaintaining ISO standardsLiaise with customers for products which are contract manufacturedReview Batch DocumentationAny other projects relating to quality standards/requirements as assigned by Quality Assurance Manager/Quality Compliance Manager.Internal comment investigationChange control, vendor certification and approval of suppliers, raw material reviewTemperature monitoringCAPA reportsAPR'sFPS approvalSupport elemental impurities, excipient risk assessments, PQR reporting and production support.Key Requirements:Educated Degree level - Chemistry, Pharmacy or Biological Science. with experience within the pharmaceutical industry, preferably within QC or QA or appropriate experience.Excellent organisational and time-management skills.Ability to leverage/collaborate effectively with internal and external stakeholdersExcellent written and verbal communication and interpersonal skills.Strong problem-solver.Resourceful.Independent.Critical thinker.Comfortable working in a busy, fast paced regulated manufacturing environment.Comfortable working in a professional, team based environment.