Bharat Serums Pharma Job Opening – QA Manager Post
Pharma job opening at Bharat Serums & Vaccine Limited 2019. Candidates with a bachelors degree in Pharmacy may apply for this job post. Candidates can apply via online mode. Check out all the details on the same below:
Bharat Serums And Vaccines Limited is one of the fastest-growing biopharmaceutical companies in India. BSV established in 1971 by the late Dr Vinod Daftary researches, develops, manufactures, and markets injectable biological, pharmaceutical, and biotechnology products. The R&D of drug delivery systems, biotechnology/recombinant therapeutics, and biological/equine products; In addition, BSV offers products in the areas of gynaecology, assisted reproductive technology, critical care, emergency medicine, neurology, nephrology, haematology, and urology. The company provides its products to retail outlets and hospitals through distributors primarily in India, as well as in the Asia Pacific, the Russian Federation, CIS countries, Latin America, Africa, and internationally.
Job Title: MANAGER QA (CR&PV)
Eligibility: B Pharma & M Pharma
Job Description
* SOP conceptualization, review and amendments periodically
* Maintaining and monitoring SOP matrix applicable for local and international Clinical trials
* Compliance of CR & PV as per currant ICH GCP, CDSCO GCP and local & international regulations; Periodic Compliance
* Face inspections from regulatory authority/ partner/others and provide compliance and CAPA towards closure of inspection by compliance
* Quality review board and periodic review meetings
* Conduct SOP training for department staff and maintain training records
* Perform periodic GCP trainings
* Perform in-house audits to ensure that the all the in-house activities are as per the SOP, GCP, and applicable regulatory requirements
* Perform audits at Investigational site to ensure that the trial is conducted as per the approved protocol, GCP and applicable regulatory requirements
* Participating in Regulatory Audits and providing compliance to Audit Report.
* Ensure CT documents/BA-BE documents are scientifically correct and meeting the applicable regulatory standards
* Identify the need for training in the department and plan training for the CR & PV team members as and when required
* Perform root cause analysis and facilitate the smooth functioning of the departmental activities
* Develop and maintain GCP/ICH compliant processes which control the quality of work
* Participating in setting up and maintaining quality systems that are compliant with applicable clinical regulations and standards
* Directly interface with clinical operation team to provide vendor, site, and internal GCP audits
* Actively lead or assist activities in the areas of Internal Quality Audits and suggest CAPA (Corrective and Preventive Actions)
* Lead auditing activities to ensure that studies are conducted in accordance with protocols, GCP, and applicable regulatory requirements
* Lead and assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements while maintaining compliance with study protocols, and set procedures
* Assisting with the clinical vendor qualification and selection process
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Production/Manufacturing/Maintenance
Role: Quality Assurance/Quality Control Manager
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