Technical Writer - Contract - Sligo
Collins Mcnicholas Recruitment
Sligo
Our client, a leading Pharmaceutical Company in Sligo, is seeking a Technical Writer for an initla 3-6 month contract. To operate as a team member within the MES team to write and execute validation test documents for POMS Electronic Batch Records and SAP Recipes. Key Responsibilites: - Liaise with validation to provide approved change control documentation for all MES system changes. - Design, create, write and execute to a high quality standard, test and validation protocols, risk assessments, and system documentation. - Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures (CIs, CIRs, MIs, MIRs and SOPs) are aligned to MES processes and vice versa. - Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access. - Participate in MES knowledge exchanges, MES Governance meetings, GMES Technical Review Board (TRB) Meetings, and manage issues, work-around and fixes identified. - Provide support to other MES system users as required to ensure business continuity. - Keep recipe authors up to date on MES changes. - Documentation of all activities in line with cGMP requirements. - Cross training within the team and training of new team members. - Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems. Job/Technical Skills. - A minimum of 2 years experience in Batch processing operations in an FDA/ HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required. - Experience in the operating in a highly automated environment and safe handling of dangerous chemicals is required for this role. - A good knowledge of IT systems/MES is required for this role. For further details, please contact Colin Byrne on 071-9142411 or email colin.byrne@collinsmcnicholas.ie. View all our jobs at www.collinsmcnicholas.ie. This job originally appeared on RecruitIreland.com.
2654 days ago