AHMEDABAD · FULLTIME
Executive, QA Validation
Amneal Pharmaceuticals
Ahmedabad · onsite · Posted 41d ago
Sourced from
Undisclosed2–5 yrsfulltimeAhmedabad
About a minute. You'll make an account on the way through.
agent · working
- Read this posting0.2s
- Found the form on Naukri · 6 questions to answer1.6s
- Decided the answers for all of them2.6s
- Tailor your résumé to this role
- Waiting for you
Section · 01
About this role
Description:
- Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable).
- Coordinate and monitor qualification activities with Engineering, Production, and Validation teams.
- Ensure qualification documentation complies with GMP and regulatory requirements. Maintain qualification schedules and ensure periodic requalification is completed on time.
- Conduct quality risk assessments using tools such as FMEA, HACCP, or risk matrices.
- Identify potential quality risks and recommend appropriate mitigation strategies.
- Ensure risk management documentation is maintained and periodically reviewed.
- Draft, review, revise, and maintain Standard Operating Procedures (SOPs), work instructions, protocols, and quality documents.
- Ensure document control procedures are followed throughout the document lifecycle.
- Coordinate periodic review of controlled documents.
- Provide training on new or revised SOPs and maintain training records.
- Identify opportunities for process improvement and quality enhancement.
- Support implementation of quality metrics and trend analysis.
- Participate in cross-functional quality improvement projects.
- Develop and review process validation protocols, reports, and validation master plans.
- Coordinate execution of process validation activities with cross-functional teams.
- Evaluate validation data and ensure processes consistently meet predefined acceptance criteria.
- Support cleaning validation, analytical method validation, and computerized system validation where applicable.
Additional Skills :
- Knowledge of GAMP 5 and 21 CFR Part 11.
- Strong Understanding of ALCOA+ principles.
- Performing risk assessments using tools like FMEA, HACCP, and risk matrices.
- Hands-on experience with IQ, OQ, PQ, and requalification of manufacturing and laboratory equipment.
- Strong Project Management Skills
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 2 years or more in 2 - 5 Years
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Section · 02
Skills
QATrend Analysisprocess validationcleaning validationGampCfrAnalytical Method Validationquality improvementHACCPProcess ImprovementSystem ValidationFMEAProject ManagementRisk ManagementManufacturingLaboratory Equipment
Section · Company
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
Employees rate it well for
Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65
Find them on