Job Description

Description:

Document Control Manager oversees the organizational management of electronic and/or paper based system including but not limited to: Batch Record Issuance, Maintenance and Retention, including Protocols, reports, log books and other GMP documents . The Manager will lead the Document Control activities in regulatory inspections by reviewing documents for accuracy and compliance.

Schedule:

1st Shift 8:00am - 4:30pm Monday to Friday

Essential Functions:

• Manage document control processes thru electronic systems and/ or paper base systems.
• Maintaining lists and postings required for both electronic and hard copy; maintain specific databases in Document Control Department.
• Oversee distribution of all Controlled Documents, printing of SOPs, Methods, Specifications, Issuing Logbooks, and coordinate Biennial SOP review.
• Collaborate with teams to complete, maintain an up-to-date Document Control Systems.
• Store, archive, and retrieve the version documents such as certificate of analysis of materials and products, logbooks, laboratory notebooks, specifications, methods, protocols, and report files.
• Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols, and other controlled documents.
• Track document approvals and any related activities and ensure on-line documents are updated and accurate.
• Solve issues concerning documentation and/or change controls as required.

Additional Responsibilities:

• Manage daily performance of staff. Ensures projects, goals and deadlines are being met. Adhere to all budget requirements. Maintain high-level of confidentiality, in regards to Company and employee information. Additional responsibilities as assigned.