Quality Control Department - Finished Product Analysis

Why This Role Matters

Quality Control plays a critical role in ensuring that finished pharmaceutical products meet regulatory, safety, and quality standards before release to the market. In formulation manufacturing (OSD and liquid), finished product analysis is the final checkpoint that safeguards patient safety and company compliance.

This role directly contributes to maintaining data integrity, regulatory audit readiness, and product quality consistency. Strong analytical expertise and investigation capabilities are essential to uphold global quality standards.

Job Description

The position is responsible for finished product (FP) testing, analytical documentation review, and compliance with GMP and regulatory guidelines. The candidate will perform or oversee analysis of formulation products using advanced analytical instruments and ensure timely release of batches.

For senior-level candidates (Assistant Manager), the role additionally involves reviewing OOS/OOT investigations, approving analytical documents, mentoring team members, and ensuring adherence to quality systems.

Candidates must have hands-on formulation experience and be flexible to work in rotational shifts as per plant requirements.

Key Features of the Role

• Finished product testing in formulation unit
• Operation and troubleshooting of HPLC and other analytical instruments
• LIMS data entry and documentation management
• Investigation and review of OOS/OOT results
• Compliance with cGMP and data integrity practices
• Audit readiness and regulatory support
• Cross-functional coordination with Production and QA

Responsibilities – Executive (2–6 Years Experience)

• Perform finished product analysis for OSD and liquid formulations
• Operate analytical instruments such as HPLC, UV, Dissolution apparatus, etc.
• Ensure proper documentation in LIMS and analytical worksheets
• Follow approved STPs, SOPs, and specifications
• Report abnormal results and support preliminary investigations
• Maintain laboratory instruments and ensure calibration compliance
• Ensure adherence to cGMP and data integrity guidelines

Responsibilities – Assistant Manager (10–15 Years Experience)

• Review and approve finished product analytical reports
• Lead OOS/OOT investigations and ensure timely closure
• Review analytical documents, STPs, and specifications
• Ensure regulatory compliance and audit preparedness
• Guide and supervise QC analysts and executives
• Coordinate with QA and Production for batch release activities
• Monitor laboratory compliance with cGMP and data integrity standards
• Drive continuous improvement initiatives in QC operations

Educational Requirements

• Bachelor's degree in Pharmacy or M.Sc (Chemistry / Analytical Chemistry) – Mandatory

Experience and Skills

Executive:
• 2–6 years of experience in finished product analysis
• Strong hands-on experience with HPLC and LIMS
• Exposure to formulation (OSD/liquid) manufacturing

Assistant Manager:
• 10–15 years of experience in formulation QC
• Strong expertise in OOS/OOT investigation and documentation review
• Experience handling regulatory audits (USFDA, MHRA, etc.) preferred

Technical Skills:
• HPLC method execution and troubleshooting
• Knowledge of dissolution testing and assay analysis
• LIMS handling and documentation control
• Strong understanding of cGMP and data integrity

Behavioral Skills:
• Analytical thinking and problem-solving ability
• Strong documentation accuracy
• Team leadership capability (for senior role)
• Ability to work under timelines and shift operations

Salary Insights

Compensation will be aligned with industry standards based on experience and expertise level. Senior candidates with strong regulatory exposure and investigation handling experience may receive higher compensation packages. Additional benefits may include shift allowance, performance incentives, and insurance coverage.

Company Overview

Aurobindo Pharma Limited is a globally recognized pharmaceutical manufacturer with strong capabilities in APIs and formulations. Unit-XII at Bachupally, Hyderabad specializes in formulation manufacturing and operates under strict regulatory standards. The company is known for its focus on quality compliance, innovation, and employee growth.

Application Tips

• Clearly mention formulation (OSD/liquid) experience in your CV
• Highlight hands-on HPLC and LIMS expertise
• For senior roles, emphasize OOS/OOT investigation exposure
• Include details of regulatory audits handled
• Showcase experience in finished product batch release support