HEAD QA in Vidit Healhcare (Injectable plant)

Job Posted on Feb 24, 2023

Recruiter Type:Company
Company Name:Vidit Healthcare (Injectable plant)
Address:Kishanpura road Paonta Sahib
Contact Person:Mr.Suresh Soni
Email Address:ss@vidithealthcare.com
Required in:Formulation
Job Department(s):Quality Assurance
Job Title:HEAD QA
Qualification:M.Pharma, M.Sc, B.Pharma
Job Details:To establish a quality management system and In Process Quality monitoring in the plant.
• Responsible to ensure proper documentation.
• 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 & Approval of product quality-related documents (Product Quality Review, Annual Product Review, Stability data, BMR/BPR, and artwork (Domestic / Export).
• To approve all batch records & release the finished product.
• Approval of protocols and reports related to validation and qualification activities.
• Approval of calibration and preventive maintenance planner and ensuring its compliance.
• To form the investigation team and monitor the effective implementation of CAPA associated with incidents, OOS, complaints, and recalls.
• Approve the master documents maintained in the department.
• 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.
• 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.
Candidate should have experience in injectable plant.
Regulatory Exposure:Not Required
Experience:More than 12years
Additional Details:Candidate should have Experience in Injectables.

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