Type : Contract
Experience / Qualification:
- Minimum experience of 8 years and above in the above role and relevant to Pharma industry.
- Responsible for review and approval of Computer system validation deliverables as per applicable IT QMS SOPs.
- Responsible for overall regulatory compliance of computerized systems used for GMP purposes.
- Responsible to conduct training in the areas of CSV and Data Integrity to facilitate validation activities.
- Responsible to support vendor assessment of IT system suppliers & compliance.
- Shall be able to communicate with business, site IT, CSV and GIDC team in English and local site language.
- Must have good knowledge of Regulations (i.e., 21 CFR Part 11, Annex 11, GMP), GAMP, CSV, QMS and documentation.
- Must have good knowledge of enterprise application used in Pharma industry, laboratory systems and manufacturing equipment automation with PLC/SCADA/IPCs.
- Must have worked on various aspects of CSV/QMS.
- Must have participated in regulatory inspections like USFDA, EU, WHO etc. & their compliance.
- Private healthcare
- Multisport Card
- Excellent career opportunity for growth in MNC
Min Experience in years : 8 years
Max Experience in years :8+ years
Recruiters Name (Full Name) : Usha Garnepudi
Recruiters contact number : +48 22 104 92 81