Manager, Document Control

Amneal India • Brookhaven, NY

2d • Onsite

About The Position

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.

Requirements

• 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.
• Lead the Document Control activities in regulatory inspections by reviewing documents for accuracy and compliance.

Responsibilities

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed