The Technical Writer/Operations Documentation Specialist role at PM Group is a dynamic and innovative opportunity to work on a client site. This position requires creating, maintaining, and improving technical documentation related to manufacturing processes, regulatory compliance, and operational procedures.
Key Responsibilities:
* Develop, write, and maintain high-quality technical documents, including Standard Operating Procedures (SOPs), work instructions, batch records, equipment manuals, and training materials.
* Evaluate and ensure that all technical documentation is in line with regulatory requirements, including GMP (Good Manufacturing Practices), FDA, EMA, and other relevant guidelines.
* Collaborate closely with cross-functional teams, including production, quality assurance, engineering, and regulatory affairs, to gather information, clarify technical details, and ensure accuracy in documentation.
* Create and update documentation to reflect changes in manufacturing processes, equipment, and regulatory standards.
* Maintain document version control, ensuring that the most current versions of documents are easily accessible to stakeholders and that outdated documents are appropriately archived.
* Review and revise technical documents to ensure consistency, clarity, and compliance with company standards.
* Develop and update training materials for employees to ensure they are equipped with the necessary knowledge on SOPs, safety protocols, and manufacturing processes.
* Support internal and external audits by preparing and reviewing technical documentation, providing explanations, and ensuring compliance with all regulatory requirements.
Requirements:
* Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Engineering, or a related field.
* Minimum of 3-5 years of technical writing experience, preferably in the pharmaceutical or manufacturing industry.
* Familiarity with GMP, regulatory standards, and industry best practices for technical documentation.
* Strong technical writing and editing skills.
* Ability to translate complex technical information into clear and concise documentation.
* Excellent organizational and time management skills, with the ability to manage multiple projects and deadlines.
* Proficiency in Microsoft Office, documentation management systems, and other relevant software tools.
* Attention to detail and a commitment to accuracy in all written materials.