Sr Executive, Lab QA
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 42d ago
Undisclosed5–8 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Review analytical data for Raw Materials (RM), Packaging Materials (PM), in-process samples, Finished Products (FP), stability samples, working standards, reference standards, and other test samples.
- Review and approve Certificates of Analysis (COAs) for RM, PM, in-process samples, FP, stability working standards, reference standards, and other test samples.
samples. - Review SOPs, STPs, specifications, and other laboratory documents.
- Verify the accuracy of data entered in LIMS and manual documentation systems.
- Review protocols and reports related to analytical method transfer, validation, verification, and waiver activities. Review analytical raw data associated with method transfer, validation, and verification studies.
- Review and approve daily verification, calibration, and qualification records of laboratory instruments and equipment.
- Review and approve Computer System Validation (CSV) documents.
- Review instrument logbooks, calibration records, and third-party calibration reports.
- Review and approve the audit trail reports for Empower and non-CDS systems.
- Review stability schedules, stability protocols and stability reports.
- Ensure data integrity and compliance with ALCOA principles and documentation practices. Verify analytical records for compliance with GLP and cGMP requirements.
- Review investigations related raw data and report i.e. OOS, OOAL/OOT, deviations, incidents, and change controls.
- Review vendor qualification reports and related documentation.
- Review reduced testing reports and related documentation.
- Review analytical data and COAs received from contract testing laboratories.
- Review and approve preparation records of reagents, mobile phases, diluents, impurity solutions, and other laboratory solutions.
- Review analytical raw data for analyst qualification and approved.
- Verify compliance of laboratory activities through documentation review.
Additional Responsibilities:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 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
Skills
QAvendor qualificationCGMPlaboratory instrumentsMethod Transferfinished productsCSVSystem ValidationContract TestingLab Qacompliance
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
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