Technical Writer

Summary : Reporting to the appropriate department based on area of expertise (Quality Assurance, Quality Control, or Manufacturing). We are seeking a detail-oriented and highly skilled GMP Pharmaceutical Technical Writer to join our team. The ideal candidate will be responsible for creating, revising, and maintaining various controlled documentation that complies with Good Manufacturing Practices (GMP) regulations and industry standards. This role will work closely with internal and client cross-functional teams, including quality assurance, regulatory, production, and project management, to ensure timely delivery, accuracy, and clarity of all technical documents essential for the manufacturing and regulatory processes in a pharmaceutical industry.

Responsibilities :

• Technical Documentation : Author, edit, and maintain a wide range of documents, including Standard Operating Procedures (SOPs), batch records, validation protocols, technical reports, change control documents, and regulatory submissions in accordance with GMP guidelines.
• Compliance : Ensure all written materials meet regulatory and GMP requirements, and align with the company's quality standards, procedures, and policies.
• Collaboration : Work closely with both client stakeholders to establish alignment on deliverables and ensure project timelines are maintained.
• Document Management : Assist in the management of controlled documents in document control systems (e.g., electronic document management systems), ensuring traceability, version control, and appropriate distribution of approved documents.
• Process Improvement : Participate in process improvement initiatives related to document control, writing standards, and compliance, ensuring continuous enhancement of documentation practices.
• Audits & Inspections : Support internal and external audits by preparing relevant documentation and ensuring that all technical writing adheres to current regulatory standards.
• Change Control : Document and track changes in manufacturing processes, equipment, and methodologies, ensuring updates to procedures and records are properly reflected.

Essential Education and Qualifications :

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