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)