Head QA – Sterile | Immacule Lifesciences | Nalagarh

Job Description

• To establish a quality management system and In Process Quality monitoring in the plant.
• Responsible to ensure proper documentation.
• Adherence to Safety and Quality policies and providing necessary support at all times.
• Ensure adherence to cGMP and regulatory guidelines by the plant personnel and the same is part of the SOPs.
• To conduct the Quality review meeting and monitor the QMS activities for timely closure.
• Review and approval of core technical documents leading the Audit Compliance, QMS Documentation, and Validation.
• To monitor & conduct Internal/external / Vendor & contract manufacturing audits as per the schedules.
• Review and management of technology transfer documents.
• Overall Monitoring of new product introduction through the technology transfer process.
• Review & Approval of product quality-related documents (Product Quality Review, Annual Product Review, Stability data, BMR/BPR, and artwork (Domestic / Export). Coordinate document submissions for
• regulatory approvals.
• To approve all batch records & release the finished product.
• To monitor the Stability study of dosage forms.
• Responsible for Batch release.
• Approval of protocols and reports related to validation and qualification activities.
• Approval of calibration and preventive maintenance planner and ensuring its compliance.
• To identify the resources for QA function and ensure optimum utilization.
• To form the investigation team and monitor the effective implementation of CAPA associated with incidents, OOS, complaints, and recalls.
• Responsible for recruiting technical competent persons in the department in handling the quality management systems.
• Approve the master documents maintained in the department.
• To approve the trend analysis reports.
• To ensure compliance of the Corrective and Preventive Actions (CAPA) necessitated through various activities such as Regulatory Audits, Market Complaints, APR, and Product Recall.
• Communicate the major product quality-related issues to Management and Regulatory Agencies.
• Planning, Implementation, and compliance of Quality management system.
• Host the Regulatory & Customer audits and preparation, review, and timely submission of audit compliance reports.
• Hold administrative rights to all software systems.
• Identification, evaluation, and Approval of outside testing laboratory.
• To ensure compliance with safety requirements, cleanliness, hygiene, and environment in the working area.
• Coordinate the vendor qualification activities and review the technical agreements.

Qualification: B.Pharma, M.Pharma, MS/M.Sc