Role Objective:

A key objective of this role is to perform analysis of raw materials, packing materials, in-process, finished product, stability and water samples as per the respective approved documents, and to maintain accurate QC records in line with GLP and GDP requirements.

Desired Candidate Profile:

- M.Sc. (Organic Chemistry) or equivalent with relevant experience in a pharmaceutical / healthcare Quality Control laboratory.
- Hands-on experience in testing of raw materials, packing materials, in-process, finished product and stability samples as per Standard Test Procedures.
- Working knowledge of QC laboratory instruments, their calibration and logbook maintenance.
- Sound understanding of GLP and GDP documentation practices.
- Exposure to SAP for material and product entries is preferred.
- Strong attention to detail, discipline and ability to coordinate with QA and other departments.

Role & Responsibilities:

- To perform all chemical analysis of RM, PM, FP, IP & Stability sample in compliance mode & maintain data available as & when required.
- Perform sampling of raw materials and packing materials.
- Calibrate various instruments used in the QC lab as per schedule, maintain the records and prepare calibration schedules.
- Test water (PW & WFI) as per SOP.
- Prepare COAs of packing materials, raw materials, in-process and finished products as required.
- Prepare standard volumetric solutions and chemical reagents as per procedure and schedule.
- Maintain temperature and humidity records of the QC area.
- Prepare working standards and maintain the records as per procedure and schedule.
- Assist QA in calibration / validation of instruments by outside agencies.
- Maintain records of chemicals list, glassware with certificates and indent of materials.




- Prepare and send samples to outside laboratories.
- Maintain outside testing reports.
- Report results for PW, WFI, bulk, finished product, packing material, raw material and stability samples as per procedure.
- Maintain daily records of ethanol stock and the related register.
- Handle and maintain logbooks of instruments and chemical testing.
- Make online entries in the SAP system for raw material, packing material and finished product.
- Prepare trends.
- Ensure proper documentation and follow GLP / GDP; be punctual and disciplined in meeting specific requirements.

Functional Skills Required:

- Quality Control Analysis (RM, PM, In-process, Finished Product & Stability)
- Instrument Calibration and Logbook Management
- Water Testing (PW & WFI)
- Preparation of Volumetric Solutions, Reagents and Working Standards
- GLP / GDP Documentation and COA Preparation
- SAP Data Entry and Trend Preparation
- Sampling and Outside Laboratory Coordination

Behavioral Skills Required:

- Strong analytical thinking and attention to detail
- Punctual and disciplined in meeting specific requirements
- High level of integrity and documentation discipline
- Ability to collaborate with QA and other departments
- Time management and ability to meet testing schedules
- Proactive approach to identifying and resolving issues

Team Size to be Manage:

- Reports to: Sr. Manager QC
- Reportee: Individual Contributor Role

Significant Links: Website: https://biotechhealthcare.com/LinkedIn: https://www.linkedin.com/company/biotechhealthcare/Instagram:

Biotech Vision Care

Biotech is an Equal Opportunity organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.

📌 Executive - Quality Control - Injectable (Ahmedabad)
🏢 Biotech Vision Care
📍 Ahmedabad