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About this opportunity :

The position is responsible for maintaining quality records and operation document control systems for the site to ensure compliance with Current Good Manufacturing Practices (cGMP) and regulatory compliance as per the Title 21 CFR Part 210, 211 and ICH Q7.

Key Responsibilities:

+ Manages the electronic document control system to become the site subject matter expert with regard to operation and functionality of the electronic document control system.

+ Manages document control systems and processes to ensure their integrity and compliance with cGMP regulations

+ Coordinates documentation activities to ensure procedures are written, edited, reviewed, and approved in a timely manner to meet established deadlines.

+ Assist in the development, approval, and issuance of quality system documents.

+ Assist in updating procedures specific to the Documentation Department.

+ Work closely with other departments to support the documentation activities. This includes the retrieving of quality documents/records/trend data and any other documentation requested during an inspection.

+ Assist in continuous improvement initiatives.

+ Assist in training new hires and departmental personnel.

+ Coordinate, lead, and oversee quality system activities.

Required Skills/Abilities:

+ A Bachelors Degree in a science field or a high school diploma and at least 2-4 years' experience in documentation systems in a FDA regulated industry.

+ Strong organizational skills and the ability to communicate to a wide variety of audiences potentially interacting with clients.

+ Strong attention to detail and self-checking skills.

+ Proficiency in Adobe Acrobat and Microsoft Office, particularly Microsoft Word and Excel.