West Pharma Technical Writer - FTC 

Ireland, Dublin 

179559847

Requirements:

• Must have a third level qualification in Engineering/Quality/Science.
• Must have 3+ years’ work experience in the Medical, Pharmaceutical, or high-volume regulated manufacturing environment
• A working knowledge of quality systems such as ISO 13485/21 CFR Part 820 and EU GMP is essential.
• Ideally have a very good knowledge of Injection Moulding (standard process and Multi component), Processing, Ancillary equipment, and automation systems.
• Ideally have excellent technical writing skills.
• Must have a working knowledge of statistics and Data analytics, SPC, and ideally the use of statistical packages.
• Must have excellent communication skills both oral and written.
• Must have knowledge in computer systems; integrated manufacturing systems; word processing and spread sheets.
• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
• Must be able to deal with all levels of employees and work across various departments
• Must be able to work in a fast-paced environment.
• Must be able to organize and prioritize tasks; be detail orientated and self-motivated.
• An ability to collaborate across functional teams and work effectively in a matrixed team environment.
• Must be able to work independently on own projects while working concurrently with all departments.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Must also be able to maintain confidentiality and resolve conflicts.
• Ability to make independent and sound judgments.
• Ability to apply lean thinking to ensure procedures flow well and avoid driving non value add activity / steps.
• Knowledge of lean and VA / NVA / Waste reduction (TIMWOOD) an advantage.

Essential Duties and Responsibilities:

• Responsible for preparation, updating and completion of documents in compliance with Quality standards.
• Responsible for coordinating and facilitating with cross functional teams to drive high quality document completion.
• Objectively leading the team to the identification and documentation of procedures which accurately reflect current practices.
• Responsible for gathering and analysing data to accurately complete documents updates and preparation.
• Ensures that all documents, SOPs, and Work Instructions comply with the Quality standards implemented in the business.
• Responsible for clearly updating and preparing SOPs and Work Instructions within the required timeframes to meet business and compliance needs.
• Participates in regulatory inspections to present information on WIs and SOPs when required.
• Continuously drive improvements to ensure that all documentation meets the needs for both the Business and customer.
• Coach and drive a culture of compliance and continuous improvement, ensuring fully training compliance for documents.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties at the request of the direct supervisor.

Delegation of Duties:

When absent from the site duties and responsibilities will be delegated to the following designates

Value Stream lead, SAP Project Lead and Operations.