Job Description
Job Summary:
We are looking for a meticulous and experienced Senior Document Control Specialist to join our team. The ideal candidate will have a strong background in document management within the pharmaceutical industry, ensuring that all documentation complies with regulatory standards and supports our quality assurance processes.
Key Responsibilities:
- Develop, implement, and maintain document control systems and procedures in a paper-based QMS.
- Manage the creation, review, approval, distribution, and archiving of controlled documents.
- Ensure all documentation complies with GMP (Good Manufacturing Practices), FDA regulations, and other relevant standards.
- Coordinate with cross-functional teams to ensure timely and accurate documentation.
- Conduct regular audits of document control processes and systems to ensure compliance and identify areas for improvement.
- Train and support staff on document control procedures and systems.
- Manage document change control processes, including tracking and implementing changes.
- Prepare and present documentation reports to senior management.
Qualifications:
- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or related field. Advanced degree preferred.
- Minimum of 5–7 years of experience in document control within the pharmaceutical industry.
- In-depth knowledge of GMP, FDA regulations, and other relevant quality standards.
- Strong organizational and project management skills.
- Excellent attention to detail and accuracy.
- Proficient in document management systems (DMS) and electronic documentation systems.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team.
Preferred Skills:
- Certification in document control or quality assurance (e.g., ISO 9001 Lead Auditor) is a plus.
- Experience with batch records, validation protocols, and other quality-related documents.
- Familiarity with international regulatory requirements (e.g., EMA, ICH guidelines).
- Experience with electronic document management systems (EDMS).
Term:
- 6-month initial term, extension likely, conversion to FTE possible
Job Tags