Industry- Pharma mandatory
Key Responsibilities:
Third-Party Quality Control:
Oversee and ensure quality compliance at third-party manufacturing units.
Conduct regular audits and resolve quality issues in coordination with manufacturing teams.
Raw Material Testing:
Facilitate raw material testing at approved laboratories and ensure timely reporting.
Review and validate test results, escalating deviations to relevant stakeholders.
Batch Release:
Coordinate batch release processes, ensuring all quality parameters are met before product dispatch.
Maintain proper documentation for batch approval and release.
Control Samples Management:
Ensure timely collection and systematic storage of control samples from all batches.
Periodically audit control samples for compliance with storage requirements.
Google Sheet Updates:
Maintain and update Google Sheets with real-time data on raw material testing, batch release, and control sample status.
Highlight and flag quality issues or deviations clearly for swift action by management.
Rigorous Follow-Ups:
Conduct persistent follow-ups with third-party manufacturers, testing labs, and internal teams to ensure timely resolution of tasks.
Track pending quality activities and prepare detailed progress reports.
Quality Issue Management:
Identify, document, and escalate quality issues to ensure prompt corrective and preventive actions (CAPA).
Collaborate with teams to resolve recurring quality concerns.
Compliance & Reporting:
Ensure adherence to regulatory standards and company policies.
Prepare and present quality reports, highlighting key issues and follow-up status.
Qualifications:
Bachelor's degree in Quality Management, Life Sciences, or related field.
Minimum of 2 years of experience in quality assurance or third-party manufacturing oversight.
Proficiency in Google Sheets and other documentation tools.
Knowledge of regulatory standards (e.g., GMP, ISO).
Skills:
Strong coordination and follow-up capabilities.
Expertise in managing data and highlighting key issues in Google Sheets.
Exceptional attention to detail and problem-solving skills.
Effective communication and interpersonal abilities.
Skills Required
Quality
Quality Control • Mumbai City, Mumbai