Project Quality Management Sr Specialist-4

3 weeks ago

Warangal Hyderabad Uttar Pradesh Nizamabad, India Sandoz Full time
Job Description

- Accomplish ITQM objectives in the assigned project by planning, executing, and evaluating quality activities (as per service description).
- Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology.
- Lead, Coordinate and control the performance of quality and validation efforts during assigned projects in accordance with specified quality standards.
- Develop a Quality / Validation strategy which defines actions, deliverables, responsibilities, and procedures.
- Verify completeness and correctness of planned qualification / validation activities via a Qualification / Validation Report.
- Write / review / approve system documentation as per applicable standards, compile input from subject matter experts and seek approval from stakeholders.
- Perform reviews to ensure compliance and adherence to corporate and regulatory policies and procedures.
- Successfully interface with all levels of management and customers or suppliers to assure a consistent supply of quality products and services.
- Partners with PM to lead project team from a quality perspective, defend quality approaches towards challengers and mediate quality-related conflicts and negotiate solutions.
- Demonstrate the value of quality products and services to the project team for increased adoption and adherence.
- Train and coach teams on quality aspects of system life-cycle processes, quality standards.
- Be process-driven and continuously strive for process improvement in the quality area. Apply and define fit-for-purpose or lean approaches.

Education

- Bachelors Degree (or equivalent) in Computer Science, Information Systems Management, Mathematics, Informatics, or other related fields.
- Certification or accreditation in Information Security (CISM, CISA, CISSP etc.) is a plus.
- Fluent in written and spoken English.
- 6-10 Years of relevant experience in BioPharma IT Quality & Compliance departments

ITQM skills

- Has successfully managed quality during multiple international and/or cross- functional IT projects and/or operations and has a minimum of six years hands-on quality management.
- Expert Knowledge and hands-on working experience of Quality and Security Management in the following areas / disciplines
- GxP, CSV and GAMP
- Good understanding of pharmaceutical validation requirements driven by health authorities like FDA etc.
- IT System Lifecycle (Requirement Management, Design, Testing, Deployment)
- Adequate project management skills to plan quality and infor-mation security tasks and monitor their implementation during as-signed projects.
- Software Development Methodologies: Agile, Dev / SecOPs
- Quality and Process Management (CMMI, Six Sigma)

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