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

Similar Jobs