Senior Executive Quality Assurance

Followings will be the Core Job Responsibilities of the position holder:

1. APQR Management

• Preparation and review of Annual Product Quality Review (APQR) as per defined SOP timelines
• Compilation of data from:
• Batch manufacturing & packing records
• Analytical results
• Deviations, OOS, OOT, CAPA
• Perform trend analysis and identify:
• Process variability
• Quality risks
• Improvement opportunities
• Ensure completeness, accuracy, and consistency of APR data
• Provide recommendations and action points based on review

1. Documentation Control
   • Ensure accuracy, completeness, and compliance of all related quality documents
   • Review and control of Supporting documents related to APQR
   • Maintain document lifecycle.
   • Ensure document compliance with applicable SOPs and regulatory expectations

2. Data Integrity & Compliance

• Ensure data accuracy and traceability in APQR and documentation.
• Verify consistency of Analytical data, Manufacturing data and QMS records for supporting APQR
• Ensure compliance with GMP documentation practices (GDP)

1. Review & Quality Assessment

• Critically review APQR data for Trends, Exceptions/Deviations and Outliers
• Highlight discrepancies between data and conclusions
• Support risk-based decision making

1. Continuous Improvement (APQR Driven)

• Identify and recommend process and product improvements
• Support closure of actions arising from APQR findings
• Strengthen documentation practices based on audit and review observations

1. Compliance & Audit Readiness

• Ensure APQR and documentation are: Audit-ready, Traceable and structured
• Support internal and external audits related to APQR & Documentation systems

1. Additional Responsibilities

• Adhere to SOPs, safety practices, and COBC requirements
• Perform any other documentation-related assignments as assigned

Key Skills
• Strong knowledge of:
• APQR / PQR requirements
• GMP & GDP documentation practices
• Expertise in:
• Data analysis and trending
• Technical writing & review
• Attention to detail and audit readiness mindset

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

India > Village Mauza : Baddi

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)