Executive, QA Validation
Amneal India · Ahmedabad, Gujarat, India
Pharmaceutical Manufacturing · 5,001-10,000 employees
8 h ago
Mid (2-5 yrs)
Full-time
India
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About the role
The role involves managing qualification and validation activities for equipment, facilities, and utilities while ensuring cGMP compliance on the shop floor. It also requires preparing and reviewing quality documentation, including SOPs, protocols, and reports for process validation and risk assessments.
What they look for
Quality Assurance
Validation
Qualification
cGMP Compliance
Standard Operating Procedures
Change Control
Deviation Management
CAPA
Risk Assessment
Process Validation
Cleaning Validation
Calibration
Injectables
Regulatory Compliance
Documentation Review
Requirements
Candidates must hold a degree in M.Sc, B.Pharm, or M.Pharm and possess 2-5 years of experience in validation within an injectables manufacturing plant. Experience working in regulated industries, specifically US or European markets, is required.
Full description
Key Responsibilities:
- Responsible for review of URS, DQ and vendor/ supplier’s documents related to qualification.
- Responsible for preparation and review of Validation/ Qualification protocol and report.
- Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities.
- Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
- Responsible for preparation and review of media fill and hold time protocol and report.
- Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
- Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc.
- Responsible to prepare protocols of process validation and cleaning verification/validation.
- Responsible to conduct sampling activity as per the protocols (Process validation and clearing validation etc.).
- Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system.
- Responsible for preparation and updation of Annual Validation Planner.
- Responsible for review of the master and executed documents of cross functional team (CFT).
- Responsible for review of master batch documents.
- Responsible to review the different type planner and calibration certificates.
- Responsible to monitor cGMP compliance at shop floor.
- Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance.
