Manufacturing Senior Associate_104865

Key Skills: Documentation., Document Controller, Manufacturing, Deviations, Pharmaceutical, Biologics

Roles and Responsibilities:

• Author, revise, coordinate, and maintain controlled GMP documents, including SOPs, work instructions, protocols, reports, forms, and training documents.
• Manage document reviews, comment resolution, approvals, periodic reviews, revision schedules, and lifecycle status tracking.
• Coordinate with Manufacturing, Quality, Engineering, Validation, and Process Development teams to ensure documentation accurately reflects approved processes.
• Support deviation documentation, investigation records, corrective actions, and compliance commitments through timely and accurate document control.
• Prepare documentation metrics, monitor overdue reviews and revision cycle times, and support audit and inspection readiness activities.
• Identify and implement improvements to documentation workflows, standardization, compliance, and right-first-time approval performance.

Skills Required:

• 5 - 9 years of relevant experience in manufacturing documentation, document control, deviations, or GMP-regulated operations.
• Hands-on experience with manufacturing documentation and controlled document lifecycle management in a GMP-regulated environment.
• Experience serving as a document controller or managing document control activities for manufacturing operations.
• Experience documenting, tracking, or coordinating deviations and related quality records.
• Strong understanding of Good Documentation Practices and cGMP requirements.
• Ability to manage multiple document revisions, stakeholder reviews, deadlines, and compliance commitments.

Good to Have:

• Experience in biologics manufacturing.
• Experience in the pharmaceutical industry.

Education: Any Graduation or Post Graduation; backgrounds in Biochemical Engineering, Biotechnology, Computer Applications, Electronics and Computer Science, Industrial Safety, or Industrial Engineering and Management are suitable.