Engineering Documentation / QMS (Pharma Industry)

Green Signal Bio Pharma; Chengalpattu; On-site; INR 600,000 - 900,000; Full time

Job summary

Green Signal Bio Pharma seeks an Assistant Manager / Senior Executive to oversee Engineering Documentation and QMS activities. You will manage SOP creation and document control, ensuring GMP compliance and cross-functional alignment across QA, Production, Purchase and Stores.

The role requires handling Change Control, Deviation, CAPA, and maintaining eQMS/digital documentation workflows with AmpleLogic. You will coordinate SAP for maintenance, procurement, and spare parts, and support audits

Qualifications

• Bachelor's or Diploma in Engineering (Mechanical/Electrical/Instrumentation).
• 512 years of experience in engineering documentation/QMS within the pharmaceutical industry.
• Knowledge of GMP, compliance documentation, and SAP systems.
• Experience with AmpleLogic or similar eQMS/eDMS platforms.
• Strong communication, coordination, and organizational skills.

Responsibilities

• Manage engineering documentation and coordinate Engineering QMS activities.
• Prepare, review, revise, and control SOPs.
• Handle Change Control, Deviation, CAPA, and engineering compliance documentation.
• Coordinate SAP activities for maintenance, procurement, and spare parts management.
• Manage AmpleLogic (eQMS/eDMS) document workflows.
• Coordinate procurement and vendor activities for engineering requirements.
• Organize engineering training programs and maintain records.
• Schedule engineering shifts and manage manpower allocation.
• Collaborate with QA, Production, Purchase, Stores, and other support functions.
• Prepare Engineering MIS reports and support audits.

Skills

GMP knowledge

Documentation control

SAP systems

eQMS/eDMS

Communication

Coordination

Organizational skills

Education

Bachelor's or Diploma in Engineering (Mechanical/Electrical/Instrumentation)

Tools

AmpleLogic

Job description

Job Title: Assistant Manager / Senior Executive - Engineering Documentation & Engineering QMS

Department: Engineering

Industry: Pharmaceuticals & Life Sciences

Location: Gummidipoondi, Tiruvallur (Chennai)

Job Summary: The role involves managing engineering documentation and coordinating Engineering QMS activities in compliance with pharmaceutical industry standards. The candidate will be responsible for SOP preparation, document control, compliance documentation, and cross-functional coordination to ensure smooth engineering operations.

Key Responsibilities:

• Manage engineering documentation and coordinate Engineering QMS activities.
• Prepare, review, revise, and control SOPs.
• Handle Change Control, Deviation, CAPA, and engineering compliance documentation.
• Coordinate SAP activities for maintenance, procurement, and spare parts management.
• Manage AmpleLogic (eQMS/eDMS) document workflows.
• Coordinate procurement and vendor activities for engineering requirements.
• Organize engineering training programs and maintain records.
• Schedule engineering shifts and manage manpower allocation.
• Collaborate with QA, Production, Purchase, Stores, and other support functions.
• Prepare Engineering MIS reports and support audits.

Qualifications & Skills:

• Bachelors degree/Diploma in Engineering (Mechanical/Electrical/Instrumentation preferred).
• 512 years of experience in engineering documentation/QMS within the pharmaceutical industry.
• Knowledge of GMP, compliance documentation, and SAP systems.
• Experience with AmpleLogic or similar eQMS/eDMS platforms.
• Strong communication, coordination, and organizational skills.