JOB TYPE: 6 MONTHS CONTRACT TO HIRE

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.

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).

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.