Job Description

The position is responsible for in-process and final product quality analyses and inspection in compliance with established standards and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision against approved specifications using defined methods, calibrated instruments, and prescribed procedures. The incumbent uses measuring devices and testing equipment to accept or reject products, tests random samples of finished goods, and audits, monitors, and determines the quality of manufacturing processes and outputs. The position identifies ongoing quality issues, prevents potential production risks, suggests improvements, and reports manufacturing process deviations and defects while maintaining robust GMP documentation and compliance.

Essential Functions:

• Perform In-Process Testing (IPT) and Finished Product (FP) Testing as per approved methods

• Execute Sampling and Testing Procedures for RM/PM/IP/FG (Raw Material / Packaging Material / In-Process / Finished Goods)

• Interpret and evaluate analytical results for accuracy and precision

• Review Analytical Data Review, Validation & Evaluation and laboratory records

• Perform accept or reject decisions based on approved specifications

• Conduct Laboratory Investigation & Change Control for deviations and failures

• Review and approve Certificate of Analysis (COA) Documentation

• Support Internal and External Audits and regulatory inspections

• Identify quality trends and support Continuous Improvement initiatives

• Ensure strict adherence to Good Documentation Practices (GDP)

• Report manufacturing process deviations and finished goods defects

• Maintain compliance with 21 CFR Part 210 & 211

Additional Responsibilities:

• To ensure destruction of solid and liquid samples which are unused/ left over after analysis. Co-ordination with other departments for sending samples for outside laboratory testing.

• Responsible for the analysis & documentation of Raw-materials and packaging materials.

• Responsible and participate to perform the investigation for Quality issues like OOS, OOAL, Incident and deviations during laboratory activities.

• Responsible for the preparation and standardization of volumetric solutions/reagents and to maintain related documents adequately.

• Responsible for the preparation, handling & management of working/reference standards.

• Responsible for the preparation of SOPs and laboratory related documents.

• To ensure that documentation is done contemporaneously and in the legible manner.

• Responsible to perform analytical method transfer and analytical method verification of Raw material. Management & planning of samples to be analysed in quality control laboratory.

• Responsible to supervise quality control laboratory activity.

• Any other activities/tasks assigned by HOD

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required

• Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: