Position to ascertain computer system validations and

1.    Ensure that Computerized System’s used in Manufacturing, Quality and various business process are validated to meet regulatory requirement (US FDA, MHRA, EMA etc.)

2.    Provide Validation support in various computerized system used in GxP functions (Manufacturing & Quality).

3.    To carry-out remediation across Manufacturing and QC system

4.    To work under guidance of IT-QA/CSV head 

Key Responsibilities:

1.    To support department head in implementation of validation and controls across-Chromatographic system  Central SCADA, Calibre LIMS, Mfg-Process Equipment, QC Equipments

2.    To carry out Gap assessment & Remediation of Manufacturing and Quality Control’s IT Systems and Computerized Equipment’s to meet regulatory requirements.

3.    To implement computer system validation (CSV) policy and procedure in coordination with Manufacturing, QC, QA and IT.

4.    To maintain computerized based controls (User Roles, System Configurations, Audit Trial etc.) in various process of across Manufacturing Plant, Engineering and QC lab having computerized based applications.

5.    To carry out regular Audit of various Computerized systems and IT Application used in Manufacturing and QC

6.    To carry-out DIRA of Mfg, QC and enterprise application and respective remediation action plan

7.    Provide Computer system validation and documentation support during regulatory inspections.

8.    To represent IT Compliance & SOP status in regulatory audits

9.    To support upgradation plan of manufacturing equipment’s to meet regulatory compliance.

10. To remain updated on latest regulatory guidelines (GAMP/21 CFR Part 11) and coordinate & support quality and manufacturing function on CSV Procedures to maintain its compliance.

11. To check compliance of GxP application server’s security & data back-up procedure.

12. Ensures that GxP based system software licensing are adhered.

13. To conduct training program on Computer System Validation & Compliance for employees.

EXPERIENCE & SKILLS REQUIRED:

·      Minimum 8 years’ experience in supporting IT Quality -Life Sciences/Pharma domain 

·      Working knowledge of Quality Management and Manufacturing & Quality applications 

·      Candidate should have strong understanding of pharma IT System

·      Active Participation experience in experience regulatory and 3rd Party inspections 

·      Understanding Pharma Regulation -21 CFR Part 11, EU Annexure-11, GAMP Guidelines, Data Integrity Guidelines and Good Documentation Practices

·      Good communication skills, should have worked independently for 4-5 years in customer facing role.

·      Minimum Qualification -MSc(IT)/BE(IT)/MCA/ B Pharma-QMS