Senior Associate, Quality Compliance

2 weeks ago


Mumbai, Maharashtra, India SUN PHARMA Full time

Responsible for reviewing site QA activities related to QC lab records, certificates of analysis/compliance, and supporting documentation. Provides role during audits.

Area Of Responsibility

  • Supports batch certification activities for USA/Canada commercial distribution.
  • Conducts investigation reviews of site incidents/deviations and ensures corrective actions are adequate.
  • Ensures compliance to regulatory requirements.
  • Provides support for all regulatory audits and inspections.
  • Participates in mock inspections to prepare for audits and identifies compliance issues.
  • Supports adherence to SOPs and policies.
  • Performs additional assignments as needed.

Work Conditions:

  • Corporate Office Environment
  • Manufacturing/Production Environment
  • Laboratories
  • Warehouse Environment
  • Field Familiarity Environment

Physical Requirements:

  • Capable of bending, lifting, and carrying up to 10 pounds.
  • Ability to navigate various working environments and wear personal protective equipment.

Travel Estimate

Up to 10%

Education and Job Qualification

  • Bachelor's degree minimum
  • Roles supporting seminars and courses are beneficial.
  • Understanding of GMPs
  • Ability to work effectively in a multicultural organization.
  • Proficiency in software applications.
  • Knowledge of project management principles.
  • Strong communication, interpersonal, and organizational skills.
  • English language proficiency at Intermediate-B1+ level.

Experience

  • Minimum of seven years in the pharmaceutical industry.
  • Experience in a multicultural organization.

Disclaimer: The job description indicates the general nature of work performed within this classification and does not contain a comprehensive inventory of all duties and responsibilities.



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