Team Member – Analytical QA

Qvents.In; Solan; On-site; INR 500,000 - 750,000; Full time

Job summary

Dr.Reddys Laboratories in Himachal Pradesh seeks a Team Member in Quality Assurance to support investigations of QMS documents, OOS/OOT, and change controls. You will review analytical data and ensure SOP compliance.

You will prepare trending reports, verify CAPA plans, and maintain calibration records, LIMS data, and stability documentation, contributing to GMP adherence and data integrity.

Qualifications

• 2+ years of Pharma QC/Analytical QA experience in a lab.
• Experience in investigations, document reviews, and instrumentation.
• Graduate in Chemistry/Analytical Chemistry or Pharmacy; masters preferred.

Responsibilities

• Investigate QMS documents (OOS, OOT, deviations) and close per SOP timelines.
• Prepare trending reports for OOS/OOT/incidents to identify CAPA and improvements.
• Evaluate Change Controls and CAPA actions for effectiveness to prevent recurrence.
• Review analytical data (electronic and raw) for accuracy and SOP compliance.
• Review instrument/calibration records and audit trails for data integrity and GMP.
• Prepare/review stability documentation and manage reference/ impurity/ working standards.
• Perform and verify SAP transactions for lab workflows and data entries per SOP.
• Review/approve method validation/transfer protocols and LIMS master data and control limits.

Skills

Pharma QC

Analytical QA

Education

Graduation in Chemistry/Analytical Chemistry or Pharmacy

Masters in Microbiology, Biochemistry, Biotechnology, Chemistry/Analytical Chemistry or Pharmacy

Certifications like CQA, CPGP, CBSP, Six Sigma, ICH Q5/Q6, RAC preferred

Tools

SAP

LIMS

Job description

Designation :

Team Member

Function :

Quality Assurance

Functional Area :

QC, Analytical

Job Role Summary :

Investigation of Laboratory incidents, OOS, OOT, QMS documents, Change management, Reviewing Analytical documents

Job Profile

• You will be responsible for participating in investigations of Quality Management System (QMS) documents such as OOS, OOT, and laboratory deviations, and ensuring timely closures as per SOP timelines.
• You will be responsible for preparing trending reports for OOS, OOT, and laboratory incidents, using analytical insights to support CAPA identification and process improvements.
• You will be responsible for evaluating Change Controls and CAPA action plans, verifying their effectiveness to ensure resolution of root causes and prevention of recurrence.
• You will be responsible for reviewing all analytical data generated in the Quality Control laboratory—including electronic and raw data—ensuring accuracy and compliance with relevant SOPs.
• You will be responsible for reviewing instrument and equipment calibration records and audit trails to confirm reliability, data integrity, and GMP adherence.
• You will be responsible for preparing and reviewing documentation related to stability samples and ensuring that reference standards, impurity standards, working standards, and related records are maintained per applicable procedures.
• You will be responsible for performing and verifying SAP transactions related to laboratory workflows and data entries as outlined in SOPs, ensuring traceability and accuracy.
• You will be responsible for reviewing and approving method validation and method transfer protocols and reports, as well as LIMS master data and control limit updates, ensuring analytical consistency across platforms

Job Requirements

• 2+ years experience in Pharma Quality control, Analytical QA functions
• Experience handling Laboratory investigations, Laboratory Document review, Analytical Instrumentation

Work / Job Experience :

2+ Years

Type of Experience :

Pharma QC, Analytical QA experience

Academic Qualifications

• Graduation in Chemistry/Analytical Chemistry or Pharmacy is mandatory
• Masters in Microbiology, Biochemistry, Biotechnology, Chemistry/Analytical Chemistry or Pharmacy is preferred
• Additional Certifications like CQA, CPGP, CBSP, Six Sigma, ICH Q5/Q6, Advanced Biologics Manufacturing or RAC are preferred

• Full Time
• India | HImachal Pradesh | Baddi
• Posted 22 hours ago

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