Deputy General Manager, QA Validation

Essential Functions:

• To ensure that validation system remain updated as per regulatory requirements and industry standards.
• Responsible for execution and review of Qualification / Re-Qualification and Validation activity ofEquipment / System / Facility and Plant utilities.
• Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respectiveQualification / Validation / Re-qualification activity for timely completion of activities.
• Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
• Responsible to conduct sampling activity as per the protocols (Process Validation, Cleaning Validationetc..).
• Responsible for preparation, review and execution of risk assessment activity related to Equipment /Process / Facility / System.
• Responsible for preparation and follow up for collection of data related to Annual validation planner.
• Responsible for submission of qualification documents to RA as per requirement.
• Responsible for review of media fill BMR.
• Responsible for IPQA activities as per requirements.
• Responsible for review and approval of documents like Validation protocols, reports, QRM, SOPs etc..
• Responsible for the assessment & review of Change Control, Deviation, CAPA, Investigation etc..
• Responsible for approval of URS, DQ and vendor/ suppliers documents related to qualification.
  Additional Responsibilities:
• Ensure readiness of validation documents and responses.
• Provide training to the validation team and relevant cross-functional personnel on new validation procedures, regulatory updates, and equipment/system validations to maintain compliance and consistency.
• Participate in Vendor Qualification and Technical Evaluation.
• Monitor and manage the lifecycle of validated systems, including periodic review, change management, and revalidation, to ensure sustained compliance and performance.
• To have cost saving, quality improvement, Time saving and innovative thinking approach.
• To have good written and verbal communication skills in English language.

Education:

• Bachelors Degree (BA/BS) B. Pharma - Required
• Master Degree (MS/MA) M. Sc - Preferred
• Master Degree (MS/MA) M. Pharma - Preferred

Experience:

• 12 years or more in 12 - 15 Years

Skills:

• Regulatory Compliance & Validation Guidelines (FDA, EMA, ICH, WHO) - Advanced
• Validation Master Plan (VMP) Development & Execution - Advanced
• Process Validation (PV) for Oncological Injectables - Advanced
• Cleaning Validation (CIP/SIP) & Residue Limit Justification - Advanced
• Aseptic Process Validation (Media Fill Studies) - Advanced
• Sterilization Validation - Advanced
• Equipment Qualification (DQ, IQ, OQ, PQ) - Mastery
• Environmental Monitoring & HVAC Qualificationn - Advanced
• Deviation Handling, CAPA & Change Control in Validation - Mastery
• Analytical Quality Assurance - Advanced
• Equipment & Facility knowledge - Advanced
• Investigation - Mastery

Specialized Knowledge: Licenses: