Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Change Control Documentation Specialist

Job Description:

The Change Control Documentation Specialist ensures that all changes to processes, equipment, and systems within the pharmaceutical plant are documented accurately, evaluated for regulatory compliance, and approved by appropriate stakeholders. This role is critical to maintaining product quality, safety, and adherence to Good Manufacturing Practices (GMP). The specialist will collaborate with cross-functional teams to track, manage, and execute change control processes, ensuring all documentation is updated, compliant, and easily accessible.

Key Responsibilities:

1. Change Control Management:

• Coordinate the initiation, review, and approval of change control documents.
• Ensure that all changes are evaluated for impact on product quality, regulatory compliance, and plant operations.
• Monitor the progress of change requests and ensure timely completion according to project timelines.

2. Documentation Review and Compliance:

• Maintain up-to-date records of all documentation related to change controls, including Standard Operating Procedures (SOPs), work instructions, and technical specifications.
• Ensure documentation is accurate, complete, and in compliance with GMP, FDA, and other regulatory standards.
• Facilitate document reviews with Quality Assurance (QA), Quality Control (QC), and other departments to ensure compliance.

3. Cross-Functional Collaboration:

• Work closely with manufacturing, quality, regulatory, and engineering teams to ensure seamless implementation of changes.
• Serve as the primary point of contact for questions regarding change control documentation.

4. Auditing and Reporting:

• Conduct internal audits of documentation to ensure ongoing compliance with regulations.
• Prepare reports and metrics on change control activities and present them to management.

5. Training and Education:

• Train staff on change control procedures, documentation standards, and compliance requirements.
• Stay updated on regulatory changes and new documentation practices, ensuring the plant's procedures remain current.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• 5+ years of experience in change control documentation, preferably in the pharmaceutical or biotech industry.
• Strong knowledge of GMP, FDA regulations, and other industry standards.
• Excellent organizational and time management skills.
• Proficiency in document management systems (e.g., TrackWise, Veeva, or similar platforms).
• Strong attention to detail and ability to work independently and within a team.

Preferred Skills:

• Experience in a regulated environment (pharmaceutical, biotech, or medical devices).
• Familiarity with quality management systems (QMS).
• Strong communication skills, both written and verbal, with the ability to train others on change control processes.
• This role is crucial to ensuring that the pharmaceutical plant operates within regulatory guidelines, minimizing risks to product quality and safety.