Technical Writer, (Compliance)

Technical Writer Industry : Pharmaceutical

Department: Technical Operations

Role Summary: Pharmaceutical company has a requirement for a Technical Writer in their Technical Operations

Compliance department in Limerick.

As a Consultant Technical Writer, a typical day may include:

• Liaise with the Automation and Validation departments in an effective and timely manner as part of generating Automated System Periodic Evaluation Program (PER Program) reports.

• Responsible for generating maintenance reports as part of the Maintenance program example review and trending of work records. Liaise with multiple departments in data review. Collate responses in a timely and effective manner.

• Facilitate reviews and revisions of Department related SOP's, life cycle documents, plans and policies for each group within the Department.

• Facilitate support of preventative maintenance record review and audit trail review.

• Ensure report writing deadlines are meet and data is concise and accurate and meets ALCOA+ principles.

• Support department in lead up to audit in preparation of support documentation.

• Support automation in administration of equipment access.

• Maintains knowledge of current good manufacturing practices (cGMPs).

This role will require the following:

• Experience working in a regulated GxP environment.

• Ability to work on own initiative, without direct supervision from management.

• Team player with an ability to work well across various departments on site as well as business partners.

• Project management skills.

• Excellent written and communication skills.

• Deadline focused individual.

Contract Duration: 12 Months

Location: Limerick

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