AQA-Executive
Sssv Solutions Visakhapatnam · Hyderabad · onsite · Posted 1d ago
About a minute. You'll make an account on the way through.
About this role
We are looking for experienced professionals in Analytical Quality Assurance (AQA) to join a reputed pharmaceutical manufacturing organization.
Role & responsibilities
Review and approve analytical data, laboratory reports and Certificates of Analysis (COAs).
Review stability data, stability summaries and holding-time studies.
Perform audit-trail reviews of QC instruments, including HPLC, GC, UPLC, UV, FTIR and Karl Fischer.
Handle OOS, OOT, laboratory incidents, deviations, CAPA and change controls.
Review and prepare SOPs, specifications, STPs, analytical protocols and reports.
Review analytical raw data, electronic records and laboratory documentation for data integrity and GMP compliance.
Review QC laboratory trends, including water testing, environmental monitoring and microbial monitoring.
Ensure compliance with cGMP, data integrity and applicable regulatory requirements.
Maintain document control and support internal, customer and regulatory audits.
Work with LIMS, CDS and other electronic quality management systems.
Preferred candidate profile
68 years of pharmaceutical experience, preferably in API manufacturing.
Strong hands-on experience in AQA / Lab QA.
Experience in analytical data review and audit-trail review.
Knowledge of OOS/OOT investigations, CAPA, deviations and change control.
Working knowledge of HPLC/GC software such as Empower, Chromeleon or OpenLab.
Experience with LIMS and electronic documentation systems is preferred.
MALE CANDIDATES ONLY
If interested kindly share your cv to- [phone removed]
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