Senior Compliance Officer

Brightwater

Waterford

A leading Pharma site in the South East requires an experienced Regulatory Affairs or Compliance officer for a 9 month contract. This role carries an attractive salary and benefits. You will ensure that Business Units operate in accordance with Regulatory, Company and Corporate requirements by providing compliance support and advice as required. Responsibilities: • To ensure manufacturing and R&D Business Units operate in accordance with Regulatory, Company and Corporate Requirements, by effectively managing Pharmaceutical Systems such as Technical Complaints, Quality Risk Management, RAMP, Metrics, Quality Technical Agreements, Vendor Management etc. • To manage a team of Quality personnel and ensure workload is managed effectively. • To support and participate in the Internal Audit Schedule and the Vendor Assurance Programme. • To participate and project manage compliance and company projects as required. • To support Regulatory and Customer Audits and ensure Risk Registers are maintained. • To participate in Knowledge Management and ensure information is shared throughout the company. • To identify areas for improvement and take corrective action as required. • Excellent planning and organisational skills to ensure workload prioritisation and schedule adherence. • An understanding of internal/external customer requirements and an ability to respond promptly to needs. • Ability to lead day to day activities and projects by providing support and guidance to team members. • Ability to work on own initiative to meet and exceed business objectives. Requirements. • Degree in pharmaceutical/life sciences with 3–5 years’ experience in a Pharmaceutical, Regulatory or Q.A. environment. • In depth knowledge and understanding for interpretation of cGMPs and regulatory requirements – FDA, HPRA, etc. • Experience of regulatory inspections and customer audits. • Strong Auditing skills and/or Lead Auditor Trained. • Proven track record of people management skills. • Good oral and written presentation skills and attention to detail are desirable attributes. • Knowledge of Company quality policies and procedures. • Technical report writing skills. • Excellent Computer skills. • Communication skills - verbal / written. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2433 days ago