DGM/AGM IT-QA and CSV

Job Description

Summary of Job Function of DGM/AGM IT-QA and CSV:

Position to ascertain Computer System Compliance and Validation at Intas manufacturing site and ensures that:

• Implement IT System Compliance and Validation controls in various GxP business process of manufacturing and quality in line with regulatory requirements pertaining to GMP/GLP/GAMP /21 CFR Part 11.
• Establish system based controls in Information technology asset used in manufacturing operation in order to enhance operational efficiency and GxP compliance
• Aligning IT system validation team and policies, supporting business and compliance objective of organization.
• Align strategic and operational support with IT-Manufacturing Head

Required Skills:

• Computer System Validation (CSV) as per 21CFR part-11, annex-11, GAMP-5 and various regulatory requirements
• Good Automation Manufacturing Practice (GAMP-V) life cycle approach for Computerized System Validation for Life Sciences industry.
• Quality Risk Management (Assessment, Control & Review) throughout life cycle as per ICH-Q9.
• Must aware of 21 CRF 210, 211
• Technical and Process knowhow of Batch Manufacturing Records, Quality Management System,
• Auditing and Regulatory Compliance requirements as per various regulatory- USFDA, MHRA, EMEA, ANVISA, WHO, TGA, MCC, Kenya, Uganda and various third party audits.
• Must aware of QMS & related practices i.e. Change management, Incident, Deviation, CAPA etc
• Auditing of IT System controls and compliance
• Must aware of SCADA & IPC controls instrumentation & their data generation structure
• Should have directly involve/faced 10-15 International Regulatory Audits
• Must aware of Good Documentation Practices (GDP), Electronic Data Governance, Controls for Data Integrity and data security policies.
• Minimum 15 years’ experience in implementation and validations and controls in IT system-based in Pharma Manufacturing and Life Cycle domain.

Key Responsibilities:

• Regularly update CSV Procedures and policies in line with latest regulatory guidelines (GAMP/21 CFR Part 11) and maintain its compliance at various site.
• To implement computer system validation (CSV) procedure and policies in various department-manufacturing, quality control, R&D, engineering, Quality Assurance etc.
• To qualify IT infrastructure of various sites.
• To validate various IT based projects (EBMR, Track & Trace, LIMS, QMS, TMS, DMS & etc.).
• To carry out validation of various SCADA based system in manufacturing equipment’s for centralized operation and integration with Electronic Batch Manufacturing Records application.
• To carry out gap assessment in reference to current regulatory requirements of various IT systems used in manufacturing and engineering.
• To Introduce computerized based controls (User Roles, System Configurations, Audit Trial etc.) in various process of Manufacturing Plant and QC lab.
• To work with site IT team to enhance compliance of IT infra of various manufacturing site.
• To implement and qualify Back-up, archival, disaster recover and BCP policies for better compliance.
• To support and represent validation of various IT applications during regulatory inspections.
• To undertake CSV related project and/or activities, assigned by department head.
• To conduct training program on Computer System Validation & Compliance for employees.
• To manage team of IT-QA and CSV personal of various site.

About the Company

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. It has been growing at about 25.5% CAGR over the last 5 years and crossed the $1.9 billion mark in the past financial year. The company has set up a network of subsidiaries, under the name Accord Healthcare in EU, US, Canada, SA, Australia, APAC as well as CIS & MENA regions. Intas is present in 85+ countries, with more than 69% of its revenue coming from global business.