Quality Specialist

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About the role:Reporting to the Qualified Person (QP), you will be a key member of the team which is responsible for providing a quality support to the Quality Systems, Operational Quality and Technical Quality teams.Our Quality Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.Main responsibilities duties:Perform distributor Audits and progress QTAs with distributorsProvide Quality Operations support to approved vendors and ensure that any risks are communicated effectivelyReview pharmaceutical product batch files for timely release by Responsible Person (RP), Responsible Person for Importation (RPi), or certification by Qualified Person (QP)Provide QA support to the business during root cause analysis investigationRaise on request or using own initiative Third party notification, CAPA, GDP issues, Deviation and Change ControlSupport activities required to effectively maintain the company Pharmaceutical Quality SystemMonitor alerts for potential overdue for Complaints, CAPA, GDP issues, Deviation and Change ControlCompliant review of batch documents in preparation for QP RPi, or RP releaseCompletion of assigned Quality and Technical Agreements to eliminate any overdueTrack and follow up on all outstanding assigned Quality and Technical AgreementsParticipate in internal and external auditsParticipate in reviews of OOS and RCAs in a timely manner, with timely escalations to HOQ/QP as requiredWork with relevant stakeholders to achieve timely completion of all CAPAs relating to Customer and Internal Audit auditsAd hoc quality support, communication of risks, and other tasks as assignedAbout you:Candidates with proven relevant experience gained within a pharmaceutical quality department are likely to have the skills required to be successful in this role. We are also looking for:Bachelors degree in Pharmaceutical Science or equivalentPostgraduate degree or diploma is desirableGreat IT skills including MS software/programsExperience gained in manufacturing, API, solid dosage forms, liquids, creams and sterile productsExperience of facilitating OOS and Root Cause AnalysisRoutine preparation of Quality and Technical AgreementsGood working knowledge of current GMP, SOPs, EU GMDP and ICH guidelines and regulationsPrevious auditing experience would be an advantageExcellent time management and organisational skills with demonstrated ability to juggle multiple competing tasks and demandsAbility to work successfully within cross-functional teams as well as independentlyExcellent professional communication skills, both written and verbalPlease use the below link for job application and quicker response.https://lifelancer.com/jobs/view/aef2440058f7e6ac477fb8f9bcf2b422

23 April 2024
Location: United Kingdom Basildon
Work type:
Full time
PLEASE! No enquiries from Recruitment Agencies or Headhunters.

Only direct applications will be considered.

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