Technical Writer/Operations Documentation Specialist
3 weeks ago
The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands.
We are looking for a Technical Writer/Operations Documentation Specialist to join our dynamic and innovative OTS team, working on a client site. The Technical Writer will be responsible for creating, maintaining, and improving technical documentation related to manufacturing processes, regulatory compliance, and operational procedures. Your expertise will ensure that all documents are accurate, clear, and compliant with industry standards and regulations.
Responsibilities
1. Develop, write, and maintain high-quality technical documents, including Standard Operating Procedures (SOPs), work instructions, batch records, equipment manuals, and training materials.
2. Ensure that all technical documentation is in line with regulatory requirements, including GMP (Good Manufacturing Practices), FDA, EMA, and other relevant guidelines.
3. Work closely with cross-functional teams, including production, quality assurance, engineering, and regulatory affairs, to gather information, clarify technical details, and ensure accuracy in documentation.
4. Create and update documentation to reflect changes in manufacturing processes, equipment, and regulatory standards. Ensure that all process changes are accurately captured in relevant documents.
5. Maintain document version control, ensuring that the most current versions of documents are easily accessible to stakeholders and that outdated documents are appropriately archived.
6. Review and revise technical documents to ensure consistency, clarity, and compliance with company standards. Ensure documents are easy to understand for various stakeholders, from production teams to regulatory authorities.
7. Develop and update training materials for employees to ensure they are equipped with the necessary knowledge on SOPs, safety protocols, and manufacturing processes.
8. Support internal and external audits by preparing and reviewing technical documentation, providing explanations, and ensuring compliance with all regulatory requirements.
Qualifications
1. Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Engineering, or a related field.
2. Minimum of 3-5 years of technical writing experience, preferably in the pharmaceutical or manufacturing industry.
3. Familiarity with GMP, regulatory standards, and industry best practices for technical documentation.
4. Strong technical writing and editing skills.
5. Ability to translate complex technical information into clear and concise documentation.
6. Excellent organizational and time management skills, with the ability to manage multiple projects and deadlines.
7. Proficiency in Microsoft Office, documentation management systems, and other relevant software tools.
8. Attention to detail and a commitment to accuracy in all written materials.
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Cork, Cork, Ireland Pm Group Full timeOverviewThe Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs.Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands.We are looking for a Technical...
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