Role & responsibilities

for Analytical services- QC

Execute analytical method validation and monitor validation parameters in compliance with ICH and ANVISA guidelines.

Prepare and review method validation protocols, raw data, and validation reports.

Perform and review formulation finished product analysis for both oral and injectable products in line with regulatory requirements.

Handle analytical instruments including HPLC, GC, FTIR, UV-Visible spectrophotometer, and water content determination by Karl Fischer.

Review analytical data and ensure compliance with approved specifications, procedures, GMP, and regulatory requirements.

Support OOS, OOT, deviation, and related analytical investigations..

FOR QA- QMS

Review chromatograms, raw data, audit trails, and analytical reports for GMP compliance.

Support OOS, OOT, deviation, and laboratory investigations.

Ensure compliance with ALCOA+ data integrity principles.

Manage Deviations, Change Controls, CAPAs, Risk Assessments,



and Investigations.

Monitor QMS metrics and prepare quality trend reports.

Support internal, customer, and regulatory audits.

Ensure QMS compliance and continuous quality improvement.

Handle Computer System Validation (CSV) and qualification activities.

Monitor LIMS data, chromatographic systems, and stability chamber performance to ensure accuracy, compliance, and quality standards.

Preferred Candidate Profile

Hands-on experience in Quality Assurance / QMS activities in the pharmaceutical industry.

Strong knowledge of GMP, ALCOA+, data integrity, investigations, CAPA, change control, and audit requirements.

Valuable documentation, review, coordination, and analytical data assessment skills.

Preferred candidate profile

Male candidate preferred

Perks and benefits

📌 Walk-ins For Quality Control (Hyderabad)
🏢 SHILPA MEDICARE
📍 Hyderabad