Pharmaguideline
Website:
pharmaguideline.com
Job details:
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 Vacancies: 1 Additional Details: Candidate should have Experience in Injectables.
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