Assistant Manager - QMS

Enzene Biosciences Ltd; Pune District; On-site; INR 600,000 - 800,000; Part time

Job summary

A biotechnology firm is seeking an experienced Assistant Manager - QMS in Pune, Maharashtra. The candidate will oversee the quality management systems, ensuring compliance with regulatory requirements and supporting digitalization efforts. Responsibilities include reviewing Change Controls, trending quality data, and conducting root cause analysis for deviations. This role is ideal for those with strong organizational skills and a background in quality assurance practices.

Qualifications

• Strong understanding of QMS elements and regulatory requirements.
• Experience in managing multiple tasks in a dynamic environment.
• Ability to perform root cause analysis and implement corrective actions.

Responsibilities

• Review Change Control and follow up on action plans.
• Monitor Quality management systems like Change Controls and CAPA.
• Review investigations related to deviations and non-conformances.
• Ensure integrity of data within quality system documents.

Skills

Quality management systems monitoring

Change Control review

Risk assessment

Regulatory compliance knowledge

Root cause analysis

Organizational skills

Job description

Assistant Manager - QMS

Join to apply for the Assistant Manager - QMS role at Enzene Biosciences Ltd.

Get notified about new Assistant Manager jobs in Pune, Maharashtra, India.

Responsibilities

• Review of Change Control, Temporary Change Control, Deviation and CAPA and follow up for closure of the action plan.
• Trending of QMS elements.
• Effective monitoring of Quality management systems like Change Controls, Deviations, OOS, Investigations, CAPA, Trainings etc.
• Ensure appropriate system for tracking and trending of Quality data and its feedback into the management review. To escape critical events to management as and when required as per the process.
• Ensure all the CAPAs and risk assessment related to client, regulatory inspections are completed on time.
• Involved in the review of investigations related deviations, non-conformances, and out-of-specification results related to drug product or drug substance, participating in root cause analysis and corrective action implementation.
• Performed the day-to-day operations of Quality management system.
• Support for implementation of digitalization project.
• Maintain a thorough understanding of regulatory requirements related to drug product manufacturing, aseptic processes, and microbiology, and apply this knowledge to enhance quality assurance practices.
• Effective organizational skills, able to manage multiple tasks and priorities within a dynamic environment.
• Ensure integrity of data within the quality system documents.
• Responsible for preparation and review of SOPs related to QA function.

Seniority Level

Mid-Senior level

Employment Type

Temporary

Job Function

Other

Industries

Biotechnology