DOCUMENT CONTROL SUPERVISOR - Exela Pharma Sciences : Job Details

Position SummaryThe Documentation Control Supervisor is responsible for overseeing the Documentation Control Unit as it pertains to processing of master documentation. This position will additionally serve as a final Quality Reviewer/Approver for internal documentation. The Documentation Control Supervisor is also responsible for overseeing the Equipment/Facility/Process Change Control Program. Further, the Documentation Control Supervisor serves as the system owner for the Enterprise Quality Management System (EQMS). Lastly, the Documentation Supervisor shall be responsible for contributing to-or leading-Quality process improvement initiatives. Job Responsibilities

• Manages the Documentation Control Unit to ensure the following:
• Document Change Controls (DCCs) are processed in a timely manner, with minimal mistakes.
• Quality databases are thorough and up-to-date to allow for analysis and trending.
• Documents are easily accessible by appropriate company personnel. Proprietary documents are secured and only made available to necessary personnel.
• Serves as the final Quality Reviewer/Approver for internal company documentation [e.g., Standard Operating Procedures (SOPs), Facility Maps, etc.].
• Oversees the Equipment/Facility/Process (EFP) Change Control Program.
• Review all documentation associated with EFP Change Controls and ensure compliance to Good Manufacturing Practice (GMP), internal Good Documentation Practices (GDPs), and internal SOPs.
• Review Impact Assessments to ensure proposed changes to company equipment, facilities, or processes are thorough, accurate, and justified.
• Advise end-users on documentation mechanisms to ensure adequate compliance to GMP.
• Leads or contributes to Quality process improvement initiatives, including but not limited to the following activities:
• Attend or host meetings to discuss new processes or changes to current processes.
• Ensure appropriate Change Control documentation is in place.
• Author new or revise existing SOPs related to the initiatives.
• Advise on documentation mechanisms to make initiatives easier for the project initiator.
• Manages the Enterprise Quality Management System (EQMS).
• Contacts external partners when required to notify of-or obtain approval for-upcoming additions/changes to manufacturing equipment, facilities, or processes in compliance with existing Quality Agreements.
• Keeps department manager up to date. Seeks guidance on resolution of complex issues.
• Acts as a resource for documentation required of various functions.
• Performs other duties as assigned.

Experience Requirements

• Ability to meet varying deadlines.
• Ability to coordinate projects involving input from multiple participants.
• Ability to work independently, when necessary.
• Proficiency in Microsoft Office applications (e.g., Excel, Word, etc.) and Adobe Acrobat.

Education Requirements

• Bachelor's Degree and three (3) to five (5) years in the Pharmaceutical Industry, preferably in a Quality Systems Role.