Back to jobs
Junior Officer
Hetero Labs LTD
Hyderabad, Telangana Full Time 150 vacancies
Salary
3 - 3 LPA
Experience
0-0 years
Applications
22
Job Description
Key Responsibilities
Quality Assurance (QA)
Documentation & Compliance
Review production and laboratory documents for completeness, accuracy, and compliance with Good Documentation Practices (GDP).
Assist in the review of Batch Manufacturing Records (BMR), Batch Packaging Records (where applicable), equipment logbooks, cleaning records, and analytical reports.
Ensure compliance with approved Standard Operating Procedures (SOPs), specifications, and quality systems.
Support document issuance, retrieval, archival, and control activities.
GMP Activities
Participate in line clearance, area clearance, and in-process verification activities.
Assist in batch release documentation review under supervision.
Monitor compliance with GMP, hygiene, and housekeeping requirements.
Support self-inspections, internal audits, and regulatory inspection readiness.
Quality Systems
Assist in handling deviations, change controls, CAPA, incidents, and investigations.
Participate in risk assessment activities and quality improvement initiatives.
Support vendor qualification and raw material qualification activities where applicable.
Participate in qualification and validation documentation review.
Quality Control (QC)
Laboratory Operations
Perform sampling of raw materials, intermediates, finished APIs, utilities, and environmental samples as per approved procedures.
Conduct routine analytical testing under supervision using approved analytical methods.
Prepare reagents, volumetric solutions, buffers, and standard solutions following SOPs.
Record analytical observations accurately in laboratory notebooks and worksheets.
Instrument Handling
Assist in the operation of laboratory instruments including:
HPLC
GC
UV-Visible Spectrophotometer
FTIR
Karl Fischer Titrator
pH Meter
Dissolution of laboratory samples where applicable
Analytical Balance
Moisture Analyzer
Perform routine calibration and verification activities as assigned.
Maintain laboratory cleanliness and instrument logbooks.
Laboratory Documentation
Follow Good Laboratory Practices (GLP) and Data Integrity (ALCOA+) principles.
Maintain analytical records in accordance with approved procedures.
Report Out-of-Specification (OOS), Out-of-Trend (OOT), abnormal observations, or laboratory incidents immediately to supervisors.
Regulatory & Compliance Responsibilities
Adhere to cGMP, GLP, GDP, Data Integrity, and company quality policies.
Follow all SOPs, specifications, protocols, and regulatory guidelines.
Participate in GMP, Data Integrity, EHS, and Quality Management System (QMS) training.
Support regulatory inspections and customer audits as required.
Safety Responsibilities
Follow Environment, Health & Safety (EHS) procedures at all times.
Wear prescribed Personal Protective Equipment (PPE).
Handle chemicals, solvents, reagents, and laboratory glassware safely.
Ensure proper segregation and disposal of laboratory waste.
Report unsafe conditions immediately.
Quality Assurance (QA)
Documentation & Compliance
Review production and laboratory documents for completeness, accuracy, and compliance with Good Documentation Practices (GDP).
Assist in the review of Batch Manufacturing Records (BMR), Batch Packaging Records (where applicable), equipment logbooks, cleaning records, and analytical reports.
Ensure compliance with approved Standard Operating Procedures (SOPs), specifications, and quality systems.
Support document issuance, retrieval, archival, and control activities.
GMP Activities
Participate in line clearance, area clearance, and in-process verification activities.
Assist in batch release documentation review under supervision.
Monitor compliance with GMP, hygiene, and housekeeping requirements.
Support self-inspections, internal audits, and regulatory inspection readiness.
Quality Systems
Assist in handling deviations, change controls, CAPA, incidents, and investigations.
Participate in risk assessment activities and quality improvement initiatives.
Support vendor qualification and raw material qualification activities where applicable.
Participate in qualification and validation documentation review.
Quality Control (QC)
Laboratory Operations
Perform sampling of raw materials, intermediates, finished APIs, utilities, and environmental samples as per approved procedures.
Conduct routine analytical testing under supervision using approved analytical methods.
Prepare reagents, volumetric solutions, buffers, and standard solutions following SOPs.
Record analytical observations accurately in laboratory notebooks and worksheets.
Instrument Handling
Assist in the operation of laboratory instruments including:
HPLC
GC
UV-Visible Spectrophotometer
FTIR
Karl Fischer Titrator
pH Meter
Dissolution of laboratory samples where applicable
Analytical Balance
Moisture Analyzer
Perform routine calibration and verification activities as assigned.
Maintain laboratory cleanliness and instrument logbooks.
Laboratory Documentation
Follow Good Laboratory Practices (GLP) and Data Integrity (ALCOA+) principles.
Maintain analytical records in accordance with approved procedures.
Report Out-of-Specification (OOS), Out-of-Trend (OOT), abnormal observations, or laboratory incidents immediately to supervisors.
Regulatory & Compliance Responsibilities
Adhere to cGMP, GLP, GDP, Data Integrity, and company quality policies.
Follow all SOPs, specifications, protocols, and regulatory guidelines.
Participate in GMP, Data Integrity, EHS, and Quality Management System (QMS) training.
Support regulatory inspections and customer audits as required.
Safety Responsibilities
Follow Environment, Health & Safety (EHS) procedures at all times.
Wear prescribed Personal Protective Equipment (PPE).
Handle chemicals, solvents, reagents, and laboratory glassware safely.
Ensure proper segregation and disposal of laboratory waste.
Report unsafe conditions immediately.
Requirements
MSc (organic, in organic, analytical, instrumental, pharmaceutical, integrated, General)