Senior Manager - QA

Sun Pharmaceutical Industries, Inc.; Indiana (PA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking experienced QA professionals to oversee market complaints and ensure compliance with quality standards. This role involves managing annual product reviews, conducting internal audits, and collaborating with corporate teams to uphold the highest quality metrics. Candidates should possess a strong background in Quality Assurance with over 15 years of experience in sterile QMS. Join a dynamic team dedicated to maintaining excellence in pharmaceutical quality and making a significant impact in the industry.

Qualifications

• 15+ years of experience in QA functions of sterile QMS.
• Strong knowledge of regulatory compliance and internal auditing.

Responsibilities

• Manage market complaints and ensure timely corrective actions.
• Conduct internal quality audits and facilitate regulatory audits.

Skills

Quality Assurance

QMS Management

Regulatory Compliance

Internal Auditing

Education

B. Pharma

BSc

B.Tech

Job description

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Company: Sun Pharmaceutical Industries Ltd

3 POSITIONS:

Location: Halol 1

Education: B. Pharma/ BSc / B.Tech

Experience: 15+ Years in QA functions of sterile QMS

JOB DESCRIPTION:

Key Responsibilities:

• Handling of market complaints received at site. Responsible for ensuring market complaints, failures, deviations are investigated and corrective and preventive actions are implemented as per set timelines.
• Review of complaints for FAR assessments and communications to Corporate Quality and US team.
• Annual Product Review/Product Quality Review management, review and approval including annual calendar.
• Ensuring management notification (Quality alerts) are effectively managed and timely notified.
• Conducting internal quality audits. Facilitate internal and regulatory agency audits, ensuring that findings from site audits are understood, assessed and addressed site wide in a comprehensive manner.
• Review of monthly report/Quality index and track Quality metrics for sustaining Site Quality Index.