Senior Executive Quality Assurance chez Abbott · India > Village Mauza : Baddi

À propos de ce poste Senior Executive Quality Assurance chez Abbott

Abbott · Sur site · India > Village Mauza : Baddi

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)

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À propos de Abbott

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, ent