Ipca is a fully integrated, rapidly growing Indian pharmaceutical company with a strong thrust on export. Ipca’a API and Formulation produced at world class manufacturing facilities are approved by leading drug regulatory authorised including the USFDA.

Post : Manager – Quality Assurance (QMS & Documentation Lead)

Summary
QMS & Documentation Lead will be a critical leader within the Quality Assurance department, responsible for overseeing the Quality Management System (QMS) and all associated QA documentation.
This role requires an individual with extensive hands-on experience in managing and driving investigations, Out-of- Specification (OOS), Out-of-Trend (OOT), Deviations, and Customer Complaints, ensuring strict adherence to USFDA and MHRA regulatory guidelines.
The successful candidate must possess a strong track record of successfully navigating and responding to regulatory inspections, particularly USFDA, and managing customer audits. This role will lead and mentor a team of 10-12 QA professionals, fostering a culture of quality, compliance, and continuous improvement.

Key Responsibilities :
• QMS Management :
* Oversee the effective implementation, maintenance, and continuous improvement of the site’s Quality Management System (QMS) in accordance with cGMP, USFDA, and MHRA regulations, o Ensure all QMS processes (e.g., change control, CAPA, training, internal audits, management review) are robust, compliant, and effectively executed, o Drive QMS reviews and updates to align with evolving regulatory requirements and industry best practices.
• Investigations & Compliance :
*  Independently lead, manage, and provide expert guidance on complex investigations related to OOS, OOT, Deviations, and Customer Complaints, o Ensure all investigations arc thorough, timely, scientifically sound, and identify root causes effectively, o Oversee the implementation and effectiveness monitoring of corrective and preventive actions (CAPA) arising from investigations.
• QA Documentation :
* Manage and maintain all QA-rclatcd documentation, including Standard Operating Procedures (SOPs), specifications, master batch records, validation documents, and quality agreements, o Ensure all documentation is accurate, current, controlled, and compliant with regulatory requirements.

• Regulatory Compliance & Audit Management :
* Act as a key representative during regulatory inspections (e.g., USFDA, MHRA), leading responses to observations and ensuring timely closure of commitments, o Manage and coordinate all aspects of customer audits, including preparation, hosting, and developing comprehensive and timely responses to audit findings, o Ensure the site’s QA operations and documentation are always inspcction-rcady for USFDA, MHRA, and other regulatory bodies, as well as customer expectations, o Actively participate in and support internal audits, including responding to audit observations and implementing necessary improvements.
• Team Leadership & Development :
*  Lead, mentor, and develop a team of 10-12 QA professionals, providing guidance, performance feedback, and opportunities for professional growth, o Allocate resources effectively, manage workload, and ensure timely completion of tasks within the team, o Foster a high-performance team environment, promoting strong communication, collaboration, and accountability.
• Cross-functional Collaboration :
* Collaborate effectively with other departments (e.g., Manufacturing, QC, Regulatory Affairs, Supply Chain) to ensure quality compliance and achieve business objectives, o Represent QA in cross-functional meetings and projects.

Location : Silvassa, U.T. of Dadra and Nagar Haveli and Daman and Diu, India
Department : Quality Assurance 
Qualification : B.Pharm / M.Pharm 
Experience : 12 to 15 years 
Team Size : 10-12 direct reports

Interested candidates can share their updated resume on our email address [email protected] with subject line “Manager – QA”

Last Date : 20th June 2025