Project Quality Management Specialist, Technology

3 - 6 years

0 Lacs

Posted:2 days ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Part Time

Job Description

Major accountabilities:

    • 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.
    • C oordinate 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. laws/regulations like CSV, SDZ Standards, the IMF, and project methodology.

Key performance indicators:

  • Quality and information management standards meet customer understood, designed into work activity, and achieved.
  • Issues and Risks during IT projects serviced by ITQM are registered.
  • Achieved quality solutions while meeting agreed targets for time, budget, and customer satisfaction

Minimum Requirements:

Education : •
Bachelor's Degree (or equivalent) in Computer Sci ence, Information Systems Management, Mathemat ics, Informatics, or other related fields.
• Certification or accreditation in Information Security (CISM, CISA, CISSP etc.) is a plus. Languages: • Fluent in written and spoken English. Experience and Skills: • 3 - 6 Years of relevant experience in BioPharma IT Quality & Compliance departments ITQM s kills
• Has successfully managed quality during multiple in ternational and/or cross - functional IT projects and/or operations and has a minimum of 3 years hands - on quality management.
• Expert Knowledge and hands - on working experi ence of Quality and Security Management in the fol lowing areas / disciplines
• GxP, CSV and GAMP
• Good understanding of pharmaceutical validation re quirements driven by health authorities like FDA etc. • IT System Lifecycle (Requirement Management, De sign, Testing, Deployment) • Adequate project management skills to plan quality and information security tasks and monitor their im plementation during assigned projects. • Software Development Methodologies: Agile (must have), Dev / SecOPs (good to have) • Quality and Process Management (CMMI, Six Sigma, good to have) • Performs a range of work, sometimes complex and non - routine, in a variety of environments. • Applies methodical approach to issue definition and resolution. • Has a sound generic, domain and specialist knowledge necessary to perform effectively in the organization typically gained from recognized bodies of knowledge and organizational information?
Other skills
• Demonstrates effective application of knowledge. • Plans, schedules, and monitors own work (and that of others where applicable) competently within lim ited deadlines and according to relevant legislation, standards, and procedures. • Contributes fully to the work of teams. • Demonstrates an analytical and systematic ap proach to issue resolution. • Takes the initiative in identifying and negotiating ap propriate personal development opportunities. • Understands how own role impacts security and demonstrates routine security practice and knowledge required for own work. • Communicates effectively, fluently both orally and in writing . C an present complex information to both technical and non - technical audiences. Open to re solving conflicts, provide/receive feedback(s) , and maintain positive work relationships.

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