Cache of job #13926607

Job Title

QA Officer - (Pharmaceutical)

Employer

ICDS Recruitment

Location

Waterford

Description

QA Officer - Co. Waterford. Job Purpose: To support the Quality Assurance Manager with the development, implementation and maintenance of quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs. To develop compliance across the site. To ensure project plans and milestones are delivered according to agreed timelines. Core Responsibilities: 1. Compliance:  To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.  Represent Quality Assurance on various projects, change controls, deviations, investigations, CAPA and document approval.  Ensure high quality output – Vigilantly watch over job processes, tasks and work products to ensure freedom from errors, omissions or defects.  Initiate action to correct quality problems and notify others of quality issues as appropriate. If a procedure does not exist, devise one (through the appropriate channels); if a process needs amending, do so through the appropriate channels. 2. Continuous Improvement:  To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members. 3. Documentation:  To ensure review of all QC and production batch documentation when required and correctly in order to achieve a high level of customer service and cGMP.  To ensure preparation of Submission Documentation in support of licence applications. 4. Leadership:  Mentoring - support company with problem solving and skill development to aid learning and early problem resolution. 5. Vendor Management:  Ensure that Vendor Management program is adhered to. 6. Technical Agreements:  Ensure that customer/ Contract services Technical Agreements are initiated and maintained. 7. Customer requests:  Ensure that all customer requests are dealt with within a reasonable timeframe. 8. Commercial Manufacture:  Review batch documentation in a comprehensive and timely manner.  Notify management of any anomalies which could impact the quality, safety or efficacy of a batch. 9. Self-Inspection Program:  Ensure Self-Inspections are completed as per the defined schedule. 10. Inspections:  Participate in outside Inspections (Customer audits / Regulatory inspections. 11. Vendor Auditing:  Lead vendor audits of GxP services as required. Minimum Qualifications & Experience sought: • Qualified to a minimum of degree level, preferably a Science degree incorporating Quality Assurance. • Ideally circa 4-5 years’ experience working in a Quality Assurance role in a manufacturing environment. • Lead Auditor qualification an advantage. • Working knowledge of Electronic systems such as TrackWise, Doc-compliance, SAP etc. an advantage. This job originally appeared on RecruitIreland.com.

Date Added

2063 days ago

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