Senior Executive - Quality Assurance (OSD/Injectable)

Alembic Pharmaceuticals Limited; Panchmahal District; On-site; INR 450,000 - 650,000; Full time

Job summary

Alembic Pharmaceuticals Limited is seeking support for quality assurance responsibilities focused on deviations, investigations, audits, and regulatory compliance. The role covers CAPA, change control, SOPs, and documentation management to ensure product quality and process integrity.

The incumbent will prepare and review reports, maintain records, and assist in audits and inspections as part of a robust QA program in our Gujarat site.

Responsibilities

• Responsible for Handling of Deviations and Related investigations.
• Responsible for Preparation of internal quality audits (self-inspection) Schedule.
• Responsible for Preparation and updating of Certified Auditors List.
• Preparation and drafting Field Alert Report.
• To prepare and review Market complaint investigation.
• Responsible for Handling of CAPA.
• Responsible for Handling of change control.
• Responsible for Audit and compliance related activities.
• Responsible for the preparation, review, and implementation of QA SOPs
• Responsible for issuance of Batch Records (BMR, BPR).
• Responsible for issuance, control and archival of Documents, registers, logbooks and loose formats.
• Responsible for preparation and Review of Site Master File (SMF).
• Responsible for assigning of document number.
• Responsible to perform any other roles and responsibilities assigned by reporting authority and department head.

Job description

Role & responsibilities:

• Responsible for Handling of Deviations and Related investigations.
• Responsible for Preparation of internal quality audits (self-inspection) Schedule.
• Responsible for Preparation and updating of Certified Auditors List.
• Preparation and drafting Field Alert Report.
• To prepare and review Market complaint investigation.
• Responsible for Handling of CAPA.
• Responsible for Handling of change control.
• Responsible for Audit and compliance related activities.
• Responsible for the preparation, review, and implementation of QA SOPs
• Responsible for issuance of Batch Records (BMR, BPR).
• Responsible for issuance, control and archival of Documents, registers, logbooks and loose formats.
• Responsible for preparation and Review of Site Master File (SMF).
• Responsible for assigning of document number.
• Responsible to perform any other roles and responsibilities assigned by reporting authority and department head.