Sr. Manager

6 hours ago

Andheri, Maharashtra, India LyfLeap Talent Solutions Private Ltd Full time ₹ 22,00,000 - ₹ 31,00,000 per year

Position Title: Sr. Manager / Assistant General Manager –Corporate Quality Assurance

Department: Quality Assurance

Location: Corporate Office with oversight for Daman, Tarapur & Jammu Plants

Role Purpose

To ensure consistent implementation of Quality Assurance systems, compliance to global regulatory requirements and continuous improvement across all manufacturing sites (Daman, Tarapur, and Jammu). The role drives harmonization of quality processes, oversees audits and regulatory inspections, and ensures adherence to cGMP and corporate quality policies.

Key Responsibilities

  • Oversee the Quality Management System (QMS) implementation across multiple manufacturing sites to ensure alignment with corporate and global quality standards.
  • Ensure compliance with international regulatory agencies such as USFDA, MHRA, WHO-Geneva, TGA, and other market-specific authorities.
  • Lead internal and external audits, including mock inspections, and support sites during regulatory audits.
  • Review and approve corporate SOPs, validation protocols, and product quality documents to maintain standardization.
  • Monitor key quality metrics (deviations, OOS/OOT, change controls, CAPA effectiveness) and drive root cause analysis with respective site QA teams.
  • Establish and maintain corporate-level quality risk management, change management, and documentation control systems.
  • Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure new product introductions meet global compliance standards.
  • Conduct periodic reviews and management presentations on compliance status, audit observations, and continual improvement initiatives.
  • Lead training and capability-building initiatives for site QA teams to strengthen compliance culture. Support in vendor qualification, technology transfers, and contract manufacturing site audits from a corporate QA standpoint.
  • Key Performance Indicators (KPIs) Regulatory compliance score and audit outcomes. Reduction in critical and major audit observations.
  • Timely closure of CAPAs and deviations. QMS harmonization and standardization across sites. Training completion and effectiveness scores for QA teams.

Desired Candidate Profile

Education: B.Pharm / M.Pharm / M.Sc (Chemistry or related discipline)

Experience: 18-25 years of experience in Quality Assurance within the Pharmaceutical industry, preferably in a corporate or multi-plant QA role.

Strong exposure to international regulatory audits (USFDA, MHRA, WHO, TGA). Proven expertise in QMS, validation, documentation, and data integrity systems.

Technical Skills: Excellent understanding of cGMP, ICH, and global quality guidelines. Proficient in handling quality investigations, CAPA management, and audit readiness. Sound knowledge of regulatory documentation, quality risk management, and data integrity principles.

Job Type: Full-time

Pay: ₹2,200, ₹3,100,000.00 per year

Work Location: In person

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