No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scope and Responsibilities
- Collaborate with subject matter experts (SMEs) to gather information and understand complex pharmaceutical processes and procedures.
- Create and maintain accurate and comprehensive documentation, including but not limited to standard operating procedures (SOPs), work instructions, protocols, batch records, and quality documents.
- Translate technical information into easily understandable and user-friendly content for diverse audiences, including employees, clients, and regulatory authorities.
- Review and edit existing documentation to ensure accuracy, clarity, and compliance with regulatory guidelines and industry standards.
- Conduct research and gather data from various sources to support the development of technical documents.
- Work closely with cross-functional teams, such as R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to gather information and ensure the accuracy and completeness of documentation.
- Collaborate with regulatory affairs personnel to ensure that all documentation complies with relevant regulatory requirements.
- Participate in document control processes, including version control, document tracking, and change management.
- Stay up to date with industry trends, regulatory changes, and best practices in technical writing for the pharmaceutical industry.
- Bachelor's degree in a relevant field (e.g., Pharmacy, Life Sciences, English, Technical Writing) or equivalent experience.
- 6 to 8 years experience as a Technical Writer in the pharmaceutical industry or related field.
- Strong knowledge of pharmaceutical processes, procedures, and regulatory requirements (e.g., GMP, FDA guidelines).
- Exceptional writing and editing skills, with the ability to convey complex technical information in a clear and concise manner.
- Proficiency in using documentation tools and software, such as MS Word, Excel, and Adobe Acrobat.
- Excellent attention to detail and ability to ensure accuracy and consistency in all documentation.
- Familiarity with document control systems and practices.
- Ability to work collaboratively with cross-functional teams and subject matter experts.
- Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.
- Good interpersonal and communication skills.
- Proactive and self-motivated.