AQA-Executive

Sssv Solutions Visakhapatnam; Telangana; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sssv Solutions Visakhapatnam is seeking experienced professionals for Analytical Quality Assurance in a reputed pharmaceutical manufacturing setup. The role involves reviewing analytical data, COAs, and stability data, and ensuring data integrity and GMP compliance across QC operations.

Ideal candidates will have strong hands-on AQA / Lab QA experience, familiarity with OOS/OOT investigations, CAPA, and change controls, and working knowledge of HPLC/GC software tools.

Qualifications

• Minimum pharmaceutical QA experience in analytical quality control or QA functions.
• Strong hands-on experience in AQA / Lab QA.
• Experience in analytical data review and audit-trail review.

Responsibilities

• Review and approve analytical data, laboratory reports and COAs.
• Review stability data and holding-time studies.
• Perform audit-trail reviews of QC instruments (HPLC, GC, UPLC, UV, FTIR, Karl Fischer).
• Handle OOS, OOT, deviations, CAPA and change controls.
• Review SOPs, specifications, protocols and reports.
• Ensure data integrity and GMP compliance of records.

Skills

AQA / Lab QA

Data integrity

cGMP knowledge

Tools

LIMS

CDS (Chromatography Data System)

Job description

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