Role Title: Technical Writer
Role Type: Permanent
Location: Co. Mayo

Overview:
We are currently recruiting a Technical Writer for a Biopharmaceutical Manufacturer based in Co. Mayo. In this role, you will be actively involved and manage the batch related CAPA’s as they arise in the business unit taking them from the initial review state through RCA, approval, batch disposition and delivery of corrective and preventive actions, liaising closely with the relevant Departments and QA Lead to ensure thorough investigation is completed and timely resolution and closure is met.

You will assist in the management and closure of existing CAPA’s through the evaluation of the current status of corrective and preventive action and co-ordination with relevant personnel to ensure robust actions are in place to prevent reoccurrence prior to closure, lead and support Continuous Improvement initiatives as required to support the overall company goals. Based on knowledge and previous site experience, you will also be requested to facilitate, support and generate RCA reports.

Responsibilities:

• Maintain strong relationships with management and colleagues including operations personnel across all shifts and the QA and Technical team. Articulate the necessary requirements in a clear, concise and persuasive manner.

• Work with the BU manager on the delivery of the goals and objectives of the team.

• Manage requirements in order to deliver the KPIs as they relate to the Product Flow function.

• Ensure effective CA and PA are put in place in response to issues arising in the business unit which are raised through the QMS systems including CAPA’s / Actions / Effectiveness Checks.

• Demonstrate active support and involvement in Continuous Improvement initiatives to enhance the Product Flow.

• Participate in GEMBA’s and Process Confirmations to identify further improvement opportunities.

• Attend daily CAPA / Core 4 Process Team meetings in order to be aware of all tasks assigned to team members and where help and support is required.

• One Vault: Review and approval of assigned documentation as deemed necessary.

• Where necessary co-ordinate RCA sessions in order to resolve issues raised through the CAPA’s.

• As requested, compile data to support the KPIs for the team.

Requirements:

• 3rd level qualification and/or 3+ years Pharma or Bio Pharma experience.

• Understanding of the requirements to work in a regulated GMP industry with knowledge of biologics/pharma operations.

• Access to global Trackwise QMS and understanding of the system is preferred.

• Knowledge of SAP preferred.

• Excellent communication skills.

• Ability to use sound judgment to make effective decisions within appropriate timeframes.

• Proven to be self-directed, self-motivated and ability to prioritise competing priorities.

• Excellent technical writing skills is a requirement for this role and previous experience on GTW i.e. opening RCC’s / LIRs / CAPA’s is preferrable in order to be successful within this role.

• Ability to generate / update SOP’s / Standard Work Instructions.