Executive-QA

Als; Navi Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Job summary

ALS in Navi Mumbai seeks a compliance professional to review documents, records, MOAs and SOPs to ensure GMP/GLP compliance and to approve or reject procedures impacting drug identity, strength, quality, and purity.

Role involves inspections, internal audits, training, regulatory updates, and CAPA investigations, with responsibility for documenting findings and updating laboratory policies to maintain regulatory standards.

Qualifications

• Knowledge of GMP, GLP and regulatory requirements.
• Experience with CAPA, OOS and deviation investigations.
• Ability to implement corrective and preventive actions.

Responsibilities

• Review analysis records, MOA and SOPs to ensure GMP/GLP compliance.
• Perform internal audits of systems, processes, and documentation.
• Support regulatory inspections and prepare compliance reports.
• Maintain up-to-date knowledge of pharmaceutical regulations and update policies accordingly.
• Assist in investigations of deviations/CAPA/OOS and document actions.

Job description

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 dataReview 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 complianceMaintain 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 regulationsUpdating or implementing policies/procedures to maintain the compliance of the laboratory.5. Handling analytical investigations/deviations/CAPA/OOSAid 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 ALSThe 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 MattersALS 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.EligibilityTo 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.How to applyPlease apply on-line and provide a resume & cover letter that best demonstrate your motivation and ability to meet the requirements of this role.