Executive/Sr Executive CSV & QA

Executive / Sr. Executive CSV & QA JOB DESCRIPTION

COMPANY: Anmeda Systems Pvt Ltd
The Executive / Sr. Executive CSV & QA will support validation, quality, and regulatory compliance activities for pharmaceutical software products. This role focuses on executing CSV deliverables, maintaining documentation, and supporting inspection readiness under the guidance of senior CSV and Quality leaders. The position works closely with Product, Engineering, QA, and Customer teams to ensure
validated systems remain compliant with global GxP regulations.

Prepare and execute Test Case and CSV documentation (URS, FS, Risk
Assessments, IQ/OQ/PQ), under supervision, and maintain requirements traceability.
Support validation activities related to software updates, patches, and
enhancements.
Follow Data Integrity principles (ALCOA+) while preparing and reviewing
documents.
Work closely with Product, Engineering, QA, and Implementation teams.
Support customer validation activities during implementation or audits.
Participate in internal reviews, training sessions, and meetings.
Follow and enforce Quality Management System (QMS) deliverables, including quality policies, SOPs, work instructions, templates, and standardized validation frameworks in line with regulatory requirements within the Organization.

Job Description / Roles & Responsibilities
Ensure all products and solutions are designed, developed in compliance with GAMP 5, to be Tested and Validated with appropriate system categorization as applicable.
Act as the Product Quality Reviewer for all software releases, patches, hot- fixes, and major upgrades, ensuring risk-based validation and documented quality decisions.
Govern change management, configuration control, and impact assessments to ensure the validated state is consistently maintained across product versions under the guidance and supervision of the Lead.
Ensure product readiness for customer audits, regulatory inspections, and supplier assessments related to quality and validation.
Identify and engage key decision-makers within prospective client
organizations to build long-term professional relationships.
Travel to customer sites as required to support business, quality, or
commercial objectives.
Maintain a professional, credible, and confident presence aligned with client and regulatory expectations.
Exceptional oral and written communication skills
Knowledge of Regulatory Guidelines, Quality Assurance, General IT Landscape, Pharmaceutical Software, GAMP5

Location - Hyderabad
Role - Executive / Sr. Executive - CSV & QA

Qualification with Stream
Graduate/Postgraduate in Science/Engineering/Pharmacy
Experience - 2-6 years of experience is preferred
Salary Offered - As per company

Type of Industry
Anmeda Systems is focused in providing innovative software solutions for Industrial Automation to various industries verticals. Anmeda Systems is specialized in providing manufacturing intelligence to various industry verticals. Anmeda Systems is expertise in Aggregation, Contextualization, Visualization and Propagation of production line data through Integrated Data Flow at production facility and allows
streamlining end-to-end process and operations. The right blends of technology, industrial automation domain experience and outcome-oriented solutions will help companies in achieving competitive advantage and meet business goals.

Brief Profile of the Company
Anmeda Systems is headquartered in silicon city Bengaluru, India and has provided customized solutions for world's topmost industrial automation companies.