Manufacturing Senior Associate

Careernet; Hyderabad; Hybrid; INR 600,000 - 1,200,000; Full time

Job summary

Careernet in Hyderabad, India seeks an experienced Documentation/Document Controller for GMP manufacturing environments. You will author, revise, and maintain controlled documents such as SOPs, work instructions, protocols, reports, forms, and training documents.

You will coordinate reviews, approvals, deviations, and lifecycle tracking across Manufacturing, Quality, Engineering, Validation, and Process Development teams to ensure documentation reflects approved processes.

Qualifications

• 5-9 years in manufacturing documentation or GMP-regulated operations.
• Experience as document controller or managing document control activities.
• Experience documenting, tracking deviations and related records.
• Strong understanding of Good Documentation Practices and cGMP.
• Ability to manage multiple revisions, reviews, deadlines and compliance.

Responsibilities

• Author, revise, coordinate, and maintain controlled GMP documents (SOPs, work instructions, protocols, reports, forms, training).
• Manage document reviews, approvals, revision schedules, and lifecycle status tracking.
• Coordinate with Manufacturing, Quality, Engineering, Validation, and Process Development to reflect approved processes.
• Support deviation documentation, investigations, corrective actions, and compliance commitments.
• Prepare metrics, monitor overdue reviews and revision cycles; support audits and inspections.
• Identify and implement improvements to documentation workflows and right-first-time approvals.

Skills

Documentation management

GMP knowledge

Deviations handling

Document control

Stakeholder coordination

Good Documentation Practices

Education

Biochemical Engineering

Biotechnology

Computer Applications

Electronics and Computer Science

Industrial Safety

Industrial Engineering and Management

Tools

Document management systems

GMP record keeping

Quality management systems

Job description

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.