Job Description
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 and 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: - Education: Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Engineering, or a related field. Advanced degree or certification in technical writing is a plus.
- Experience:
- Minimum of 2 years of experience in technical writing within a GMP-regulated environment in the pharmaceutical, biotech, or related industry.
- Experience writing technical documentation, including SOPs, validation protocols, and reports.
- Knowledge:
- Solid understanding of GMP regulations (FDA, EMA, ISO, ICH, etc.) and regulatory requirements for pharmaceutical manufacturing.
- Proficiency with document management systems and Microsoft Office Suite (Word, Excel, PowerPoint).
- Skills:
- Exceptional written and verbal communication skills, with a strong ability to translate complex technical concepts into clear, concise documentation.
- Detail-oriented with strong organizational and project management skills.
- Ability to work independently, manage multiple projects simultaneously, and meet deadlines in a fast-paced environment.
- Strong analytical and problem-solving skills, with the ability to work cross-functionally across departments.
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