Technical Writer

2 months ago

Dublin, Ireland West Pharmaceutical Services Full time

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Please Note - This position is an FTC

Summary: It is expected in this role to have the ability to act independently and proactively to ensure timely completion of document updates related to the Manufacturing, Engineering, Supply Chain and Quality departments within the business. This role will work with cross-functional teams to effectively prepare new documents or update existing documents with accurate detail.

Reporting to the SAP Project Lead or Business Unit Manager, this role ensures compliance to the Quality Management System and drives efficiency through effective and accurate Document preparation and updates.

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

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