Engineering QMS - Lead - Unison Pharmaceuticals

Unison Pharmaceuticals

Company

Location

Designation : Upto Manager

Job Role/Position:

Experience Required

Key Responsibilities

• Preparation, review, and implementation of

  SOPs

  in line with

  GMP compliance

  .
• Review and control of

  daily operation logbooks

  and

  engineering documentation

  .
• Operation & Maintenance knowledge of

  utility equipment, HVAC, and water systems

  .
• Handling

  breakdown maintenance

  of utility and process equipment.
• Initiation, handling, and documentation of

  QMS activities

  : Change Control, Deviation, CAPA, etc. (EQMS software exposure preferred).

• Departmental training coordination

  and managing training records in

  TIMS software

  .
• Preparation & review of

  Preventive Maintenance (PM) planners/records

  .
• Preparation & review of

  Calibration planners, records, and certificates

  .
• Coordination and follow-up for

  calibration/validation activities

  .
• Qualification/Validation of HVAC and Utility systems, including preparation & review of

  DQ, IQ, OQ, PQ, RQ documents

  .
• Exposure to

  PLC/SCADA validation

  of utility & process equipment (CSV).
• Review & evaluation of

  breakdown maintenance sheets

  for utilities/process equipment.
• Review & updating of

  plant and utility drawings

  .
• Participation in

  regulatory and customer audits

  .

Desired Candidate Profile

• B.E./B.Tech in relevant engineering field.
• 1015 years of

  Engineering-QMS experience

  in a

  pharmaceutical OSD facility

  .
• Strong knowledge of

  GMP guidelines, regulatory requirements, and audit readiness

  .
• Hands-on exposure to

  QMS software, training tools, and compliance systems

  .
• Excellent leadership, coordination, and documentation skills.
  

What We Offer

• Opportunity to work with a growing and reputed pharma company.
• Exposure to global

  regulatory audits

  and modern

  EQMS systems

  .
• Professional growth with continuous learning and development.
  

Interested candidates can share their CVs at sandipnair@unisonpharmaceuticals.com with subject line: Application for Engineering – QMS”

Regards

Sandip

HR Department