Team Member AQA

Job Summary
This role is for a Quality Assurance Specialist  AQA reviewer - review of analytical data  Analytical Compliance responsible for ensuring end-to-end adherence to regulatory standards and SOPs in Quality Control (QC) laboratory operations with a focus on analytical data integrity and documentation oversight.

Roles & Responsibilities
You will be responsible for reviewing all analytical data generated in the Quality Control laboratoryincluding electronic and raw dataensuring 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 review of Audit trail for Quality control

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.

Qualifications :

Educational qualification: Graduation in Chemistry/Analytical Chemistry or Pharmacy is mandatory
Masters in Microbiology Biochemistry  Biotechnology Chemistry/Analytical Chemistry or Pharmacy is preferred

Minimum work experience:
5 years experience
Skills & attributes &Critical exposures
Functional Skills
Regulatory Compliance
Technical Documentation
Change Control
Laboratory Information
Risk Management
Chromatography
Resident Skills
Product Quality (QA/QC)
Current Good Manufacturing Practices (cGMPS)
Good Laboratory Practice (GLP)
Quality Management Systems (QMS)
   Behavioural Skills
Accuracy & Discipline Upholds rigorous documentation and testing standards to ensure error-free compliant results.
Ownership Proactively identifies risks supports investigations and maintains equipment readiness with accountability.
Continuous Learning Shares knowledge with new joiners troubleshoots effectively and contributes to laboratory excellence.
Critical exposures
Experience in ensuring compliance with GMP GLP and global regulatory standards is desired.
Exposure to executing analytical tests using techniques like HPLC GC FTIR and UV-Vis ensuring adherence to SOPs and regulatory requirements is preferred.
Experience in maintaining accurate documentation and ensuring compliance with data integrity principles such as 21 CFR Part 11 and Annex 11 is desired.
Experience in troubleshooting like Out-of-Specification (OOS) results and non-conformances applying analytical methodologies to resolve deviations is desired.

Remote Work :

No

Employment Type :

Full-time