Job Overview
-
Date PostedSeptember 17, 2022
-
Location (State / UT)
-
Expiration dateAugust 7, 2024
-
Experience15 Years, 22 Years
-
GenderAny
-
Desired QualificationBachelor Degree, Master’s Degree
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