Quality Assurance Assistant Manager

Sunita Tripathi

Email: ad5m4m@r.postjobfree.com Phone: +1-224-***-****

Summary

Results-oriented and knowledgeable Quality Assurance Assistant Manager with a Master’s degree in Microbiology and 6+ years of experience in pharmaceutical quality assurance. Skilled in ensuring compliance with regulatory standards like USFDA, ICH & ISO, conducting quality audits, and managing documentation. Presently seeking a Quality Assurance Manager job with a forward-moving company to leverage expertise in ensuring product quality and patient safety. Work Experience

Worked with Olive Healthcare, Daman, India as a QA Manager from July 2021 to September 2021.

Worked with Olive Healthcare, Daman, India as a QA Assistant Manager from April 2007 to April 2012.

Roles & Responsibilities

Prepared ACTD and CTD Dossiers.

Managed SOPs for entire plant.

Conducted process/cleaning validation activities.

Management of change control and deviation.

Responsible for Investigation of commercial product complaints.

Conducted in-process checks for compliance with GMPs.

Appointed MR for ISO standards.

Collaborate on developing, implementing, and maintaining the global QA program.

Manage audit and inspection processes, issue resolution, and program drug supply.

Ensure projects and programs adhere to company SOPs and worldwide regulations (EU Directives, US FDA, ICH, National guidelines).

Focus on routine commercial manufacturing to ensure quality product availability.

Approve labeling, batch records, and associated documentation.

Collaboratively review deviation investigations and out-of-specification/trend investigations.

Handle commercial product complaints for investigations and corrective actions.

Reconcile product complaints related to adverse events with pharmacovigilance.

Manage change controls effectively.

Implement quality agreements with vendor partners to enhance clarity and cooperation.

Ensure compliance with corporate SOPs, GMPs, and applicable regulations.

Contribute to continuous improvement efforts by providing a monthly quality and readiness dashboard.

Skills

Proficient in FDA regulations and other relevant regulatory requirements.

Experienced in implementing and managing QMS processes to ensure product quality.

Thorough understanding and adherence to GMP guidelines for pharmaceutical manufacturing.

Skilled in identifying, assessing, and mitigating risks associated with product quality and manufacturing processes.

Proven track record of preparing for and successfully navigating regulatory audits and inspections.

Strong ability to analyze data and trends to drive quality improvements and decision-making.

Excellent communication skills for effectively liaising with cross-functional teams, regulatory agencies, and external stakeholders.

Demonstrated leadership abilities in leading and motivating QA teams to achieve quality objectives.

Proficient in identifying and resolving quality issues, conducting root cause analysis, and implementing corrective actions.

Proactive in promoting a culture of continuous improvement by implementing best practices and quality methodologies.

Past Projects Experience

Olive Healthcare, Daman, India July 2021 – September 2021 Role: QA Manager

Responsibilities:

• Oversee QA activities for soft gelatin capsule manufacturing.

• Ensure Compliance with regulatory requirements & standards.

• Supported the Senior Quality Manager with various tasks as assigned and assisted in the development and implementation of new quality control policies to increase efficiency and reduce unnecessary expenses.

• Monitored and analyzed production processes and procedures, completed detailed reports, and maintained relevant documents and records.

• Coordinate Quality Events (Deviations, CAPAs) with management.

Olive Healthcare, Daman, India April 2007 – April 2012 Role: QA Assistant Manager

Responsibilities:

• Managed quality assurance operations for soft gelatin capsule manufacturing facility.

• Ensured compliance with ISO standards and regulatory requirements.

• Prepared documentation for accreditation processes.

• Support regulatory agency inspections.

• Author and manage Audit Plans and Audit Reports.

• Perform and/or review impact assessments and risk assessments.

• Coordinate Quality Events (Deviations, CAPAs) with management. Academic Details

Master of Science [Microbiology] in 2006 from Veer Narmad South Gujarat University, Surat, Gujarat, India.

Bachelor of Science [Microbiology] in 2004 from Veer Narmad South Gujarat University, Surat, Gujarat, India.

References

Available upon request.

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