Assistant Manager Engineering QMS

We are looking for a proactive and detail-oriented Assistant Manager QMS to support our Engineering team and ensure compliance with global regulatory standards. The role involves managing documentation, audits, deviations, and continuous improvement initiatives in alignment with company and regulatory requirements.

Role & responsibilities

Responsible for incident Investigation, Root Cause Identification, impact evaluation and defining CAPA.

Responsible for CAPA extrapolation, CAPA tracking and implementation.

Responsible for CAPA & Change Control effectiveness check.

Responsible for preparation of Quality documents.

Support OOS, OOT & Market Complaint investigations.

Responsible to follow and maintain the cGMP and documentation procedure all over the work area.

Ensure to follow the companys safety, health and environmental policy.

Ensure to carry out the subordinates job in their absence.

Maintain Environment, Health and Safety system as per ISO 14001:2015 & ISO 45001:2018

Responsible to address the Audit queries.

Key Competencies:

Good knowledge of QMS.

Good coordination with various stakeholders.

Good communication & interpersonal skills

Education Qualification: B. Pharm / M. Pharm with 5-10 or more years of relevant experience

Preferred candidate profile

• Quality Management Systems (QMS)
• Good Manufacturing Practices (GMP)
• CAPA Management
• Documentation & Change Control
• Audit Management (Internal & External)