Deputy Manager

Experience: Not Available to Not Available years

Location: Corporate Office, Ahmedabad, Gujarat, India

Skills: Method validation, Microbiology test procedures, Quality system, Microbiology instruments, Risk assessment, Compliance verification, Regulatory inspection, GMP consultant audit, CAPA, Regulatory documents, Central Quality Policy, Regulatory guidance, GMP trends

Job Responsibilities
Sr. No. Job Responsibilities ELEMNETS TO BE INCLUSIVE OF : Method validation of microbiological test procedures Quality system applicable to Microbiology Qualification (Microbiology instruments/Equipment’s) Risk assessment of EM/Grid profiling To prepare and review audit agenda based on site performance and expected regulatory inspection at site. To review of the compliance index and QMS trend for preparation of audit agenda. To prepare and review audit report and submit to respective site on completion of audit, participate in audit opening and closing meetings. To plan & execute additional audits/review based on management need and guidance. To ensure execution of Corporate Quality Audit for quality systems as per SOP.



To ensure holistic compliance need/expectations for the CAC/Regulatory/GMP consultant audit findings. To ensure compliance verification of identified CAC/External SME/regulatory CAPA for adequacy during periodic or verification audits and off-site review, as applicable. Report compliance status during periodic departmental & management review. To assist site for readiness during regulatory or GMP consultant inspections, as needed. To review the draft response for adequacy prior to submission to regulatory/SME agency. Preparation of compliance reports periodically for the respective sites for management review. To maintain repository of regulatory documents (report, response, & certificates) in portal and update the status in departmental/management review meetings. System harmonization-Identification of need & escalation. Participation in development of recent initiatives as needed. To participate in Central Quality Policy preparation, review and implementation. Update self with current regulatory guidance/GMP trends, current industry knowledge regarding the system and provide required inputs for strengthening the audit plan.

📌 Deputy Manager (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad