| 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 |
| Vacancies: | 1 |
| Additional Details: | Candidate should have Experience in Injectables. |
HEAD QA in Vidit Healhcare (Injectable plant)
Job Posted on Feb 24, 2023
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