Assistant Manager / Deputy Manager

Greetings From Immacule Lifesciences Pvt Ltd (New Plant)

We are Hiring for Quality Assurance Department

Sub Departments : QMS. Qualification & Validation

Positions: Assistant Manager / Deputy Manager

Experience: 10 -15 Years

Job Location : Nalagarh, Himachal Pradesh

Role & Responsibilities:

1. For Quality Management System (QMS):

• Implementation, maintenance, and continuous improvement of QMS as per cGMP, USFDA, EU-GMP guidelines
• Preparation, review, approval, and control of SOPs, policies, manuals, and quality documents
• Handling

  Change Control, Deviations, Incidents, OOS/OOT, and CAPA

• Root cause analysis, impact assessment, risk management, and effectiveness checks of CAPA
• Periodic review of quality metrics and trending of quality events, etc.
  

2. For Qualification & Validation:

• Review and approval of

  DQ, IQ, OQ, PQ

  documents
• Equipment qualification & validation of:

• Vial filling line

• Ophthalmic line

• PFS (Pre-Filled Syringe) line

• Manufacturing vessels

• Autoclaves

• HVAC systems

• Water systems (PW, WFI, Pure Steam)

• Review and approval of

  Process Validation, Cleaning Validation, Media Fill, and CSV

  documents, etc.

Eswar.reddy@Immacule.in