Vacancy For Team Member -ITQA CSV -(SAP)-Hyderabad. Job Vacancy in Hetero Drugs Madhapur, Hyderabad, Telangana – Updated today
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Company Name : Hetero Drugs
Location : Madhapur, Hyderabad, Telangana
Position :
Job Description : Job Description
Vacancy for Sr.Executive /Asst.Manager -ITQA CSV -(SAP)-Hyderabad
Position -Team Member
Departement – ITQA CSV-(SAP)
Exp-3-10
CTC -upto 10 LP.a
Qualification – Bsc / Msc / B Pharm / M Pharm
Industry -IT
Role & Responsiblity :
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
9. Manage authoring of Risk Assessments.
Manage authoring, dry running, & review & approval of IQ, OQ and PQ test scripts.
Special Skills: (Managerial & Functional) :
Functional: CSV SAP
Interested Candidate share resume email id ;Shirisha.M@heterodrugs.com
Regards
Shirisha.
Role:Test Analyst
Salary: 6,00,000 – 10,00,000 P.A.
Industry:IT Services & Consulting
Functional Area:Engineering – Software
Role Category:Quality Assurance and Testing
Employment Type:Full Time, Permanent
Key Skills
QAconfigurationcsv sapvalidation
Education
PG:M.Pharma in Any Specialization
Company Profile
Hetero
M/s. Hetero Drugs Ltd is one of the Largest Pharmaceutical Company in India.
Company Info
X
Contact Company:Hetero
Address:7-2-A2,,,Hetero Corporae,Industrial Estate,Sanath , Nagar, Hyderabad, Telangana, India
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