Cache of job #13887515

Job Title

Gmp Executive (Pharm)

Employer

ICDS Recruitment

Location

Dublin South

Description

GMP Executive - Dublin. • Based within the Dublin manufacturing facility, your role will be part of the Production Support Business Unit, supporting a variety of key areas onsite. You will be working across cross-functional teams with a high-level of autonomy. • This position will report into the GMP & Training Lead. The successful candidate will play a key role in implementing quality standards across each of the Production Business Units. Key Responsibilities include: • Quality Representative for operational department impacting projects. • Provide Quality support for process/product investigations, follow up corrective actions identified through the Deviation system. • Implementation of CAPA’s from LQT e.g. Deviations, Customer Complaints. • Track, trend and drive continuous improvements for timelines of QMS. • Ensure ongoing quality compliance through routine Gemba walks of Business Unit areas, active participation in Audit Readiness activities. • Implementation of the Production Department's Continuous Audit Readiness Program. • Support inspections by third parties e.g. HPRA, FDA, customers etc. • Review and Technical Approval of controlled documents including LPRs, SOPs etc. • Update of department documentation as applicable. • Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities. • Support production related activities as required. • Training of new personnel. • Participate in daily department briefings on performance. • Provide quality performance information as required. • Ensure regular Quality interaction with other Departments via daily and other operational meetings. • Provide regular updates/reports to site management and/or support departments on department quality results and trends. • Investigation of Environmental Excursions. • Support the process change control system. Interested applicants should have: • Third level qualification in science, engineering, business information systems or other relevant discipline. • At least 3 years’ experience in a quality or production function within the pharmaceutical industry. • Experience working in an FDA and/or European regulatory environment is preferred. Furthermore, you should possess the following competencies/skills: • Cross-functional/team-working. • Leading change and driving improvement. • Influencing others. • Self-starter, take initiative, work with minimal guidance and drive progress. • Excellent communication skills. • Presentation skills. This job originally appeared on RecruitIreland.com.

Date Added

2170 days ago

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