Executive-QA

alsglobal; Navi Mumbai; Presencial; INR 800.000 - 1.200.000; Jornada completa

Descripción de la vacante

ALS in Navi Mumbai is seeking a GMP compliance specialist to review documents, approve procedures, and assess qualification and software validation records. You will work under GMP/GLP standards, perform internal audits, and support regulatory inspections.

You will train staff on GMP requirements, maintain up-to-date knowledge of pharmaceutical regulations, and help implement corrective actions. The role emphasizes documentation, cross-functional collaboration, and ensuring laboratories stay

Responsabilidades

• 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-conpliances, 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 new 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 product quality.
• Facilitate the implementation of Corrective and Preventive Actions (CAPA) to address issues and prevent recurrence.
• Document findings, results, and corrective actions in accordance with regulatory requirements.
• Approval of laboratory investigations/change control/hypothesis testing plan for OOS investigation.

Descripción del empleo

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.

1. 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).
2. 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.
3. 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.
4. 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 new policies/systems to make laboratory compliant to prevailing regulations
   Updating or implementing policies/procedures to maintain the compliance of the laboratory.
5. Handling analytical investigations/deviations/CAPA/OOS
   Aid investigation of deviations, non-conformances, or complaints related to product quality.
   Facilitate the implementation of Corrective and Preventive Actions (CAPA) to address issues and prevent recurrence.
   Document findings, results, and corrective actions in accordance with regulatory requirements.
   Approval of laboratory investigations/change control/hypothesis testing plan for OOS investigation.

Working at ALS

The ALS team is a diverse and dedicated community united by our passion to make a difference in the world.

Our values are important to us, and shape how we work, how we treat each other and how we recognise excellence.

At ALS, you'll be supported to develop new skills and reach your full potential. We invest in our people with programs and opportunities that help you build a diverse career with us.

We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and our communities.

Everyone Matters

ALS is proud to be an equal opportunity employer and is committed to fostering an inclusive work environment where the strengths and perspectives of each employee are both recognised and valued.

ALS also welcomes applications from people with all levels of ability. Reasonable adjustments to support candidates throughout the recruitment process are available upon request.

Eligibility

To be eligible to work at ALS you must be a Citizen or Permanent Resident of the country you are applying for, or either hold or be able to obtain, a valid working visa.