Quality Assurance Lead - India - Qinecsa Solutions

    Qinecsa Solutions
    Qinecsa Solutions India

    1 week ago

    Description

    Job Title: Lead, Quality Assurance & Regulatory Compliance

    Primary Responsibilities

    • Assure that CRO Operations remains in compliance with corporate policies and procedures and all applicable worldwide regulations & guidelines.
    • Deploy, Manage & improve quality management system and create awareness across the organization.
    • Plan & roll out regulatory readiness program for eventual regulatory audits.
    • Ensure effective execution of the readiness program.
    • Assess the effectiveness of inspection readiness by coordinating and conducting internal and external compliance audits and applicable assessments (e.g. inspection readiness assessments).
    • Provide consultation to operations & business enabling functions personnel on Requirements (Organization, regulatory & client) & compliance issues.
    • Impart awareness session on applicable regulations (FDA, MHRA etc.).
    • Lead cross-functional teams to help identify potential issues and resolve current issues.
    • Manage compliance issues across organization and escalate issues to Qinecsa QA management as appropriate.
    • Directly manage & coordinate internal and external compliance auditing programs at Qinecsa.
    • Support Operations staff in the use of integrated quality systems; summarize quality reports and provide quality metrics as appropriate.
    • Oversee CAPA management & facilitate effective corrective and preventive action (CAPA) closure.

    Secondary Responsibilities

    Maintain quality service and departmental standards by:

    • Reading, understanding, and adhering to organizational standard operating procedures (SOPs)
    • Assisting in establishing and enforcing departmental standards

    Contribute to team effort by:

    • Working with internal staff to resolve issues
    • Exploring new opportunities to add value to organization and departmental processes
    • Helping others to achieve results
    • Performing other duties as assigned

    Maintain technical and industry knowledge by:

    • Attending and participating in applicable company-sponsored training

    Qualifications

    Education : Bachelor's or Master's degree in Pharma/ life sciences or equivalent in a related discipline

    Experience : 6-8 years of relevant experience

    Additional Skills

    • Strong motivational skills and abilities, promoting a team-based approach
    • Strong interpersonal and communication skills, both verbal and written in English
    • Strong organizational and leadership skills
    • Goal-oriented
    • Ability to maintain professional and positive attitude

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Quality assurance lead