Quality Assurance Lead

4 weeks ago

india, IN Qinecsa Solutions Full time

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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