Executive - Quality Control - Injectable

Biotech Vision Care; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Biotech Vision Care in India is seeking a QC Analyst to perform comprehensive chemical analyses of raw materials, packing materials, in-process, finished products and stability samples in strict compliance with GLP and GDP.

The role requires hands-on testing, instrument calibration, accurate data recording, and timely COA preparation. SAP data entry for material and product entries is preferred, with strong attention to detail and cross-department collaboration.

Qualifications

• M.Sc. (Organic Chemistry) or equivalent with relevant experience in a pharmaceutical / healthcare Quality Control laboratory.
• Hands-on experience in testing of RM, PM, IP, FP 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.

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.

Skills

QC testing experience

GLP/GDP knowledge

Instrument calibration

Attention to detail

Cross-department coordination

Education

M.Sc. in Organic Chemistry

Tools

SAP data entry

Job description

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

Important 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.