Senior Executive, QA Validation at Amneal India

Sanand, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

11 May, 26

Salary

0.0

Posted On

10 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Validation, Cleaning Validation, Equipment Qualification, Aseptic Processing, Sterile Manufacturing, Autoclave Validation, HVAC Validation, Media Fill Validation, Lyophilizer Qualification, WFI System Qualification, Annex 1, USFDA Guidelines, WHO Guidelines, PIC/S Guidelines, ALCOA+ Data Integrity, Sampling Techniques

Industry

Pharmaceutical Manufacturing

Description

Process Validation Plan, execute, and document Process Validation (PV), Cleaning Validation (CV), and Re-validation for injectable products. Prepare and review validation protocols and reports (IQ, OQ, PQ). Equipment & Utility Validation Perform validation of: Autoclaves, depyrogenation tunnels, sterilizers Vial washing machines, filling lines, lyophilizers Utilities: WFI, Pure Steam, HVAC, compressed air Ensure calibration and qualification of critical instruments. Aseptic Process Validation Execute and evaluate Media Fill (Aseptic Process Simulation) studies. Ensure sterility assurance and contamination control compliance. Cleaning Validation Develop cleaning validation strategies for: Product changeover Worst-case product selection Conduct swab and rinse sampling. Documentation & Compliance Prepare and maintain: Validation Master Plan (VMP) Risk assessments (FMEA, QRM) SOPs related to validation Ensure compliance with cGMP, WHO, USFDA, EU-GMP requirements. Deviation & CAPA Management Investigate validation deviations and implement CAPA. Participate in change control and impact assessments. Audit Support Support regulatory audits and customer audits. Present validation documents to inspectors. Coordination Work with Production, QC, Engineering, and QA for validation activities. Train manufacturing personnel on validation-related SOPs Skill Set Required Process Validation - Proficient Cleaning Validation - Proficient Equipment Qualification -Proficient Aseptic processing and sterile manufacturing - Proficient Autoclave validation - Proficient HVAC validation - Proficient Media fill validation -Proficient Lyophilizer qualification - Proficient WFI system qualification -Proficiency Annex 1 (EU-GMP) - Advanced USFDA, WHO, PIC/S guidelines - Advanced ALCOA+ data integrity principles - Advanced Sampling techniques (swab & rinse).- Advanced Risk assessment tools: FMEA, HACCP, QRM -Advanced

Responsibilities

The Senior Executive, QA Validation will be responsible for planning, executing, and documenting process validation for injectable products, including cleaning validation and equipment validation. They will also ensure compliance with regulatory requirements and support audits.