Position: Senior Manager, CSV QA, NOIDA

Department: Information Technology | Role: Full-time | Experience: 15 to 20 Years | Number of Positions: 1 | Location: NOIDA

Skillset:

Quality Assurance, Drug Safety, GxP, CSV, GAMP 5, CFR, EU Annex 11, ICH, GDP, Stake Holder Management, 21 CFR Part 11, Argus, Aris, Excellent English communication skills

Job Description:

Essential Duties & Responsibilities:

The candidate must possess experience in the GxP IT Compliance areas and CSV, a good understanding of regulations for LifeScience industries such as GAMP 5, CFR , EU Annex 11, ICH, GDP, GTP, GDP, PICs etc. Knowledge on Validation and Testing of Software Products is desired.

1. CSV:

• Provide Software development, Software implementation and Cloud validation expertise on GxP products for drug safety space.

• Be an SME in CSV practice and ensure best practices are followed consistently within the organization

• Facilitate adoption of CSV best practices into the organization's application, services and Cloud management.

• Represent the organization to customer meetings/discussions and ensure confidence in our deliverables

• Hands on experience and be accountable in reviewing and supporting key CSV deliverables – Requirement Specifications, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report, Risk Assessment, Qualification Scripts, Disaster Management, BCP, Internal Tool Validations, Periodic Reviews and Validation Summary Report

• Lead in maintaining the organization's QMS towards best practices of GxP practices.

• Understanding of implementing projects on SaaS Models

• Coordinate with stakeholders and communicate effectively

• Interact with internal product owners and client users to understand business, regulatory, functional & non-functional requirements or improvements for software product. Review, understand and ensure that the requirements are detailed, un-ambiguous, complete and testable.

• Lead, mentor & guide the team members for all type of testing activities and artefacts including (but not limited to) system testing, functional testing, manual testing, automation testing, OQ, PQ, IQ, etc.

• Review the work performed by the team members, provide feedback to ensure adherence to the validation and documentation practices and be accountable for the quality of work products created by the team.

• Sound Defect management skills

• Well experienced in doing Root cause aligning to practices of 5 Why Analysis, FishBone, FMEA and other statistical techniques

• Provide adequate understanding and expertise on Change Control Procedure, Deviation Handling, Document Management and CAPA management

• Understanding of risk-based system validation approach and V-Model

1. Quality Assurance Operations:

• Knowledge of GxP, GDP, GTP ,QA best practices

• In depth understanding of the regulatory guidelines for IT systems– primarily FDA, EMA, MHRA and PMDA

• In depth understanding of 21 CFR Part 11, EU Annex 11 compliance

• Minimum 10 years of experience of client, internal and regulatory audits

• Anchor updates to QMS

• Engage in Continual Improvement programs

• Coordinates the revision, review, and approval of IT SOPs and other GxP documents

• Train resources

1. Team and Stakeholder Management Skills:

• Client engagement and ability to convince based on company's Best Practices

• Ability to manage Stakeholder needs and do multi tasking

• Oversee work of direct reports and cross-train staff on different quality areas

• Interview, hire, train, develop and manage employees

• Capacity planning and forecasting resource requirements

• Performance evaluation and appraisals

• Motivating agent for the team and fosters the spirit of teamwork

• Coach, mentor and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities

• Closely work with clients, project team and product owners to support product releases and implementations

1. Other Must-have skills:

• Well-organized and detailed oriented professional, with strong verbal and written communication skills

• Self-motivated with ability to manage, organize and prioritize multiple tasks

• Should be able to achieve the optimum balance for Quality vs. Productivity

Minimum Requirements:

• Exposure to pharmacovigilance domain and drug safety applications - Argus or ArisG / J is Mandatory

• Experience with electronic QMS / DMS is a plus

• Experience in Manual execution and ALM Tool based executions

• Experience with training coordination and management

• Worked in Agile / Scrum team structure

• Experience in SQL and PLSQL writing

Qualifications:

• BE / B.Tech. - IT / CS / MCA / B.Pharma / M.Pharma from recognized institute with good academic scores

• IT Quality Assurance professional with 14 years of experience with computerized system validation in Life Sciences industry

Travel Expectations:

0%- 5% travel

Additional Information:

• We are open to consider relocation for this role

• Max official notice period acceptable for this role is 50 days

• This is 5 days work from office role

Required Qualification:

Master of Pharmacy (M.Pharm) ,Master of Computer Applications (M.C.A.) ,Bachelor of Pharmacy (B.Pharm.) ,Bachelor of Engineering / Bachelor of Technology / BSC - IT / CS

With a Top Pharmacovigilance IT Products MNC