Senior Manager Quality Assurance (Contract Manufacturing)

Classic Search Pvt Ltd; Bengaluru; On-site; INR 1,400,000 - 1,800,000; Full time

Job summary

Classic Search Pvt Ltd in Bengaluru seeks a Senior Manager Quality Assurance to lead contract manufacturing quality and compliance across Pharma, Cosmetics, and Food products. You will oversee audit programs, CAPA, deviations, OOS, and training to sustain high GMP standards.

Role demands hands-on quality governance, site visits to CM locations, and collaboration with R&D, production, and suppliers to ensure regulatory compliance. Travel will be required.

Qualifications

• Experience in handling international audits.
• Audits of contract manufacturing locations and vendors.
• Strong GMP knowledge for pharma, personal care and food products.
• Hands-on ERP experience with SAP and LIMS.

Responsibilities

• Lead contract manufacturing quality and compliance activities.
• Review and approve SOPs, validation protocols and reports.
• Coordinate with CM locations, vendors, external labs, R&D and production for compliance.

Skills

International audits

Contract manufacturing

GMP compliance

Quality Assurance

Team leadership

Education

M. Pharma or equivalent

Tools

SAP

LIMS

Job description

Senior Manager Quality Assurance (Contract Manufacturing is a must)

Experience: 1722 Years
Education: M. Pharma or equivalent
Location: Bangalore

Key Requirements

• Experience in handling and facing international audits.
• Experience in conducting audits of contract manufacturing locations and vendors.
• Strong shop-floor exposure with sound process knowledge in manufacturing of:
• Semisolid dosage forms
• Solid oral dosage forms
• Liquids
• Powder dosage forms
• Thorough understanding of GMP guidelines and regulations applicable to Pharma, Personal Care and Food products.
• Hands-on experience with ERP systems such as SAP, LIMS, etc.
• Strong process understanding with proven experience in direct team handling.

Role Expectations

• Lead overall contract manufacturing quality and compliance activities for Pharma, Cosmetics and Food products.
• Independently review and perform critical quality activities.
• Travel to contract manufacturing locations for GMP compliance and investigational audits.

Key Responsibilities

• Implement and ensure Quality and Compliance at contract manufacturing locations.
• Ensure audits of contract manufacturing locations, vendors and external laboratories are conducted and compliance is verified.
• Ensure effective implementation of Quality Management Systems, including:
• Change Controls
• Deviations
• Out of Specification (OOS)
• Market Complaints
• Training
• Ensure organizational quality objectives and compliance requirements are achieved.
• Regularly visit contract manufacturing locations and identify and mitigate risks that could lead to non-conformances or product failures.
• Ensure thorough investigation of product failures, market complaints and non-conformances.
• Ensure effective implementation and closure of CAPA, including CAPA effectiveness.
• Implement a quality rating system for contract manufacturing locations and monitor site performance.
• Ensure timely escalation of quality failures and issues to management.
• Review and approve SOPs, validation protocols and reports.
• Review and approve Master Formula Records (MFRs) and batch manufacturing & packing records.
• Review and approve stability protocols and reports.
• Coordinate with contract manufacturing locations, vendors, external laboratories, R&D, Production and other concerned teams for compliance activities.
• Supervise and monitor day-to-day Quality Assurance activities and review team performance.
• Conduct training for subordinates and contract manufacturing teams on GMP, Data Integrity and GLP.
• Ensure preparation and review of monthly quality reports.
• Participate in and conduct Quality Review Meetings to address Quality Improvement Plans.

Candidate Profile

Candidates with strong experience in Quality Assurance, Contract Manufacturing, GMP compliance, audits, investigations, CAPA and pharmaceutical manufacturing processes will be preferred.