Senior Officer, Quality Control

Amneal Pharmaceuticals LLC; Ahmedabad District; Sur place; INR 450 000 - 750 000; Plein temps

Résumé du poste

Amneal Pharmaceuticals LLC in Ahmedabad is seeking a QC Analyst to perform in-process and finished product quality analyses in line with specifications, standards and regulatory requirements. You will interpret data, operate calibrated instruments, and support acceptance/rejection decisions while ensuring robust documentation.

Responsibilities include testing RM/PM/IP/FG, reviewing COA documentation, monitoring processes for OOS/OOT, and contributing to CAPA and deviation management to sustain

Qualifications

• Bachelor’s degree in science required.
• Master’s degree preferred.
• 3+ years in pharmaceutical QC/QA environment.
• Experience with in-process and finished product testing.

Responsabilités

• Perform In-Process Testing (IPT) and Finished Product (FP) Testing as per approved specifications
• Interpret and evaluate analytical results for accuracy, precision, and compliance
• Execute Sampling and Testing Procedures for RM/PM
• Review and approve Certificate of Analysis (COA) Documentation
• Conduct Review of Analytical Data and ensure data integrity
• Identify quality issues and support Change Control & Deviation Management
• Review and investigate OOS and OOT results
• Ensure compliance with regulatory requirements and GDP
• Maintain Good Documentation Practices (GDP) and laboratory records
• Support internal and external audits and regulatory inspections
• Report manufacturing deviations, defects, and improvement recommendations

Connaissances

Analytical testing

Data integrity

Regulatory compliance

Formation

Bachelor's degree in science (BA/BS)

Master's degree in science (MS/MA)

Outils

LIMS

COA documentation

Description du poste

JOB DESCRIPTION

The position is responsible for in-process and final product quality analyses and inspection in compliance with established specifications, standards, and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision using approved methods, calibrated instruments, and defined procedures. The role tests random samples of finished goods, audits and monitors manufacturing processes and outputs against internal and regulatory standards, and identifies ongoing quality issues to prevent potential production risks. The position supports accept/reject decisions, reports manufacturing process deviations and defects, maintains robust documentation, and contributes to continuous improvement in product quality and compliance.

Description

JOB DESCRIPTION

The position is responsible for in-process and final product quality analyses and inspection in compliance with established specifications, standards, and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision using approved methods, calibrated instruments, and defined procedures. The role tests random samples of finished goods, audits and monitors manufacturing processes and outputs against internal and regulatory standards, and identifies ongoing quality issues to prevent potential production risks. The position supports accept/reject decisions, reports manufacturing process deviations and defects, maintains robust documentation, and contributes to continuous improvement in product quality and compliance.

Essential Functions

• Perform In-Process Testing (IPT) and Finished Product (FP) Testing as per approved specifications
• Interpret and evaluate analytical results for accuracy, precision, and compliance
• Execute Sampling and Testing Procedures for RM/PM (Raw Material / Packaging Material)
• Review and approve Certificate of Analysis (COA) Documentation
• Conduct Review of Analytical Data (RM/PM/FG/IP/IV) and ensure data integrity
• Identify quality issues and support Change Control & Deviation Management
• Review and investigate Out-of-Specification (OOS) and OOT (Out of Trend) results
• Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations – Current Good Manufacturing Practice for Drugs)
• Maintain Good Documentation Practices (GDP) and laboratory records
• Support Internal and External Audits and regulatory inspections
• Use analytical instruments and measuring devices for accept/reject decisions
• Report manufacturing deviations, defects, and improvement recommendations

Additional Responsibilities

• To be responsible for Investigation related to LIR, deviations, OOS and OOT.
• To be responsible for Initiation of Deviations, OOS, OOAL, CRN and CAPA's.
• To be responsible for Handling of Caliber e-LIMS
• Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HOD's instruction and guidance.

Education

QUALIFICATIONS

• Bachelors Degree (BA/BS) B. Sc. - Required
• Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 3 years or more in 3 - 6 Years

Specialized Knowledge:

Licenses: