QA Specialist

CPL

Dublin West

Job Purpose: Responsibility for carrying out tasks pertaining to compliance and product quality. The QA specialist will to partner with relevant departments to ensure that key quality systems/metrics are operated and maintained in a compliant manner. The QA specialist should partner with site functions and their customers on related Quality activities including regulatory compliance, technical, systems and reporting. This can include but is not limited to material /component/batch disposition, documentation management and approval of product record reviews, investigations, complaints, change controls, audits, quality agreements, stability, validation , supplier management and regulatory documentation. This job description is designed as a combined list of the general tasks expected of a QA specialist. Personnel may be asked to perform some or all of the tasks listed as required by their functional area. The contents of this document are not intended to be exhaustive and additional duties as may be directed by the QA Lead. Reporting Structure: Quality Site Leader. ⇧ Quality Assurance Manager/Lead. ⇧ QA Specialist. Job Responsibilities: General. • Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, regulatory requirements and industry standards. • Partner closely with customers and stake-holders to understand and deliver on all records within timelines and escalate when necessary. • Participate in cross functional teams as required to provide consultative support on quality related issues. Provides support with investigations and resolution of discrepancies e.g. Method 1 etc. Assures completeness in terms of root cause, action taken, and CAPA. • Authors, tracks, review for adequacy: procedures, investigations, commitments (Regulatory Agency, investigation, audit, etc), change controls, forms, logbooks, protocols and reports etc. People / Values: • Demonstrate the GC OWNIT values. • Adhere to all HR Policies as appropriate. • Personal Development plans focus on the 70:20:10 guidelines. • CI tools/- capability is a key building block for learning & development - Trained and M1 certified. • Proactive engagement with key stakeholders. • Best practices developed and shared with other teams /sites. • Best practices actively sought and copied. • Proactive & effective communication within and across shifts. Education/Experience: • Relevant Third Level Qualification or Equivalent (Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel. • Previous relevant Quality experience as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company. • Excellent communication and interpersonal skills. • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment. • This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required. This job originally appeared on RecruitIreland.com.

2332 days ago