Hetero Drugs Limited Released Job Openings On 02/03/2022. Hetero Drugs Limited is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.Interested and eligible candidates can submit application along with resume.
Vacancy Details:
Hetero Drugs Limited Recruiting Bsc,Msc,B Pharm,M Pharm with 3-10years experience for Sr.Executive /Asst.Manager -ITQA CSV -(SAP) Position.Complete Details for the Sr.Executive /Asst.Manager -ITQA CSV -(SAP) as follows.
Important Details :
- Location : Hyderabad
- Departement : ITQA CSV-(SAP)
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: upto 10 LP.a
- Opening date for online Application: 02/03/2022
- How To Apply:Interested Candidate share resume email id ;Shirisha.M@heterodrugs.com
Related Job : Emcure,Pfizer,Aurobindo,AstraZeneca,Dr. Reddys,Hetero Latest Openings
Job Description/Skills Required
1. Knowledge of project management with hands-on experience in the validation and configuration of computerized application (Like: SAP, SAP S/4HANA, DMS, QMS, LMS etc.,) as per business and regulatory requirements
2. Knowledge of CSV principles and regulatory guideline for Computerized and Automated Applications.
3. Knowledge of 21 CFR part 11, GAMP 5 guideline Preparation of CSV qualification protocol, review and execution (IQ, OQ and PQ) as per Lifecycle management SOP for Computerized and Automated Manufacturing System for remediated equipment.
4. Knowledge of Quality management system (Change controls, Deviation, CAPA, incidents etx)
5. Understand clients Quality and Risk management strategy, define and align with the processes and procedures for the program / project
6. Assist in strategy: inputs during define phase of CSV projects
7. Considerable experience in IT project CSV and proven ability to lead validation activities of complex IT projects This should include: understanding the business; determining business system requirements; regulatory understanding of FDA, MHRA and other key regulations
8. Professional Attributes: Provide SME support on topics relevant to GxP , Annex 11 etc
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