Senior Executive Quality Assurance

     

JOB DESCRIPTION:

Job Description                               

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

2. 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

3.    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)

4.    Review & Quality Assessment
•    Critically review APQR data for Trends, Exceptions/Deviations and Outliers
•    Highlight discrepancies between data and conclusions
•    Support risk-based decision making

5.    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

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

7.    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)