Manager QA

Keka Inc.; Dharwad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Keka Inc. in India seeks a Manager to oversee QMS, Validation & Qualification, document review and compliance oversight, including OOS investigation and IPQA activities. The role ensures GMP compliance and continuity of operations during ORS expansion.

Strong focus on Documentation, Data Integrity and Audit readiness to support product quality. Candidate should hold a Bachelor of Pharmacy with 4-5 years in QA (OSD Formulations) and demonstrate cross-functional quality governance and training

Qualifications

• Bachelor of Pharmacy with 4-5 years of QA experience (OSD Formulations).
• Experience in GMP/QA/QMS activities and documentation review.

Responsibilities

• Quality assurance & GMP Compliance oversight.
• Deviation, CAPA & Change control management.
• Process and Manufacturing Oversight.
• Quality Risk management participation.
• Qualification & Validation oversight.
• Documentation & Data Integrity maintenance.
• Internal Audit & Inspection readiness.
• Product Quality & Annual Product Quality Review involvement.
• Stability & Market Complaint Oversight.
• Training & Quality Culture promotion.

Skills

Quality assurance

GMP Compliance

Deviation

CAPA & Change control

Process Oversight

Quality Risk management

Documentation & Data Integrity

Internal Audit

Training & Quality Culture

Cross Functional Quality Governance

Education

Bachelor of Pharmacy

Job description

A Manager position is required to effectively manage and monitor QMS-related activities, Validation & Qualification including document review, approval, and compliance oversight, Complaint investigation, OOS Investigation, IPQA activity as well as to ensure continuity of operations.

Furthermore, with the ongoing ORS expansion project, extensive qualification and validation documentation activities are required. Adequate managerial support is essential to facilitate the execution, review, and closure of these activities while ensuring compliance with GMP standards and regulatory expectations.

• 1.Quality assurance & GMP Compliance.
• 3.Deviation, CAPA & Change control.
• 4.Process and Manufacturing Oversight.
• 5.Quality Risk management.
• 6.Qualification & Validation.
• 7.Documentation & Data Integrity.
• 8.Quality Systems Management.
• 9.Internal Audit & Inspection Readiness.
• 10.Product Quality & Annual Product Quality Review.
• 11.Stability & Market Complaint Oversight.
• 13.Training & Quality Culture.
• 14.Cross Functional Quality Governance.

Qualifications & Experience Required:

Bachelor of Pharmacy with 4-5 years of experience in QA (OSD Formulations).