06 Oct
|
ALS
|
Navi Mumbai
At ALS, we encourage you to dream big.
When you join us, you’ll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future.
• Review of Documents and Records:
• Review analysis records, MOA and SOPs to ensure compliance with GMP and regulatory requirements.
• Approval or rejection (as applicable) of procedures or specifications impacting the identity, strength, quality, and purity of the drug product/drug substance.
• Review of qualification/Calibration records through hard copy as well as electronic data
• Review of software qualification documents (IQ, OQ, user acceptance testing).
• Inspection and Auditing:
• Perform inspections of laboratory areas to ensure that procedures and conditions are consistent with GMP/GLP standards.
• Conduct internal audits of systems, processes, and documentation to identify non-conformances and areas for improvement.
• Participate in regulatory inspections and audits conducted by health authorities.
• Independently handle customer audits, defend established policies,
Investigation of the cited non-compliances, preparation of compliance reports, implementation of corrective and preventive actions.
• Training and Compliance:
• Provide training to staff on GMP, SOPs, regulatory requirements and updates.
• Ensure that all personnel are adequately trained in their roles and maintain competency in performing their tasks.
• Maintaining Regulatory compliance
• Maintain up-to-date knowledge of pharmaceutical regulations and industry standards.
• Monitoring of the new guidances /regulations, Monitoring updates to existing guidances/regulations. Based on the applicability, devise recent policies/systems to make laboratory compliant to prevailing regulations
• Updating or implementing policies/procedures to maintain the compliance of the laboratory.
• Handling analytical investigations/deviations/CAPA/OOS
• Aid investigation of deviations, non-conformances, or complaints related to pr
📌 Executive-QA (Navi Mumbai)
🏢 ALS
📍 Navi Mumbai