Compliance Documentation Specialist - Co

Pe Global

Cork

PE Global are currently recruiting for a Documentation Specialist for a client site in Cork: This role will be responsible for supporting the Vaccine Compliance & Documentation Group in the management of the IPT GMP documentation, and in supporting the Compliance Documentation functions in various administrative duties. Ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to our customers. This requires the delivery of compliance excellence to deliver all components Good Documentation Practices, supported by a flexible, collaborative, multi-skilled teamwork environment. Key Responsibilities: The Documentation Specialist is accountable for the smooth execution of all appropriate documentation associated within the Vaccine IPT. He/She will contribute to the High Performance culture within the Vaccine IPT by providing a flexible, accurate service to enable the IPT to achieve four key priorities. The Documentation Specialist is an active member of the cross functional IPT Team, providing support, guidance and expertise to ensure the success of the Vaccine IPT. The Documentation Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership, as relevant to you. Updating of procedural documents; Preparation of change control documentation; Processing of documentation through the Change Control System; Review of batch records and recording of incidences of corrections made to batch records; Generation and control of protocols. Quality & Safety Compliance monitoring including reporting, metrics, etc. Investigation Support. Issuance of documents to the Operations Department. Any other duties assigned by your lead. Qualifications, Skills & Experience Required - 4+ years’ experience of working in a similar documentation related role in the Pharmaceutical Industry. Knowledge of EU/US quality related pharmaceutical regulations. Degree in Science or related discipline preferable. Computer literacy. Strong communication skills. High level of technical aptitude. Demonstrated initiative and pays attention to detail. Good presentation skills. Motivated. Highly disciplined and organized. Ability to organise & coach less experienced colleagues in the group. Good social skills. Ability to work as part of a team. Interested candidates should send their CV to audrey.brennan@peglobal.net or call 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

2102 days ago