Quality Assurance Manager (OSD Facility)

Immacule Life Sciences; Solan; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Immacule Life Sciences in Solan, Himachal Pradesh, seeks a Senior QA/Quality Assurance Lead to own the Quality Management System implementation and ensure regulatory compliance across operations. Based in Solan, you will drive quality governance and readiness for audits.

You will review and approve critical documents, manage data integrity, training and supplier oversight, lead the QA team, and promote a strong quality culture throughout the organization.

Responsibilities

• Overall responsibility for implementation and compliance of the Quality Management System (QMS).
• Review and approval of quality documents (SMF, VMP, SOPs, BMR/BPR, specifications, validation/qualification, calibration and PM schedules).
• Review and approval of complaints, change controls, OOS/OOT, recalls, mock recalls and related regulatory communications.
• Ensure compliance with cGMP/regulatory requirements and approve/reject materials and finished products for release.
• Manage CAPA, investigations, risk management, data integrity and QMS activities.
• Ensure effective IPQA, validation, stability, self-inspection and audit programs.
• Review and approve Technical/Quality Agreements and monitor contract manufacturers, suppliers and external laboratories.
• Ensure plant readiness for regulatory, customer and GMP audits and timely closure of observations.
• Drive regulatory/pharmacopoeial changes and quality requirements for new product introduction/technology transfer.
• Conduct Quality Review Meetings and ensure timely closure of QMS activities.
• Develop Quality strategy and promote a strong quality culture across the organization.
• Lead, develop and manage the QA team, including manpower planning, work allocation, KRAs and performance assessment.
• Ensure adequate manpower, budget and resources for effective functioning of the Quality function.
• Ensure timely escalation and effective communication of critical quality issues to management.

Job description

Role & responsibilities

• Overall responsibility for implementation and compliance of the Quality Management System (QMS).
• Review and approval of quality documents including SMF, VMP, SOPs, BMR/BPR, specifications, validation/qualification documents, calibration and PM schedules.
• Review and approval of complaints, change controls, OOS/OOT, recalls, mock recalls and related regulatory communications.
• Ensure compliance with cGMP/regulatory requirements and approve/reject materials and finished products for release.
• Manage and monitor CAPA, investigations, risk management, data integrity and QMS activities.
• Ensure effective implementation of IPQA, validation, stability, self-inspection and audit programs.
• Review and approve Technical/Quality Agreements and monitor contract manufacturers, suppliers and external laboratories.
• Ensure plant readiness for regulatory, customer and GMP audits and timely closure of observations.
• Drive implementation of regulatory/pharmacopoeial changes and quality requirements for new product introduction/technology transfer.
• Conduct Quality Review Meetings and ensure timely closure of QMS activities.
• Develop Quality strategy and promote a strong quality culture across the organization.
• Lead, develop and manage the QA team, including manpower planning, work allocation, KRAs and performance assessment.
• Ensure adequate manpower, budget and resources for effective functioning of the Quality function.
• Ensure timely escalation and effective communication of critical quality issues to management.

Preferred candidate profile