Sr Assoc - QA QMS (JR 158668)
Company: Baxter
Location: Ahmedabad, Gujarat, India
Overview:
As a member of the Baxter Quality team, you will play an essential role in ensuring patient safety by maintaining quality throughout the product lifecycle. Quality roles provide opportunities for growth, learning, and a successful career that impacts people’s lives daily.
What You'll Be Doing:
Implement and maintain Quality Management System (QMS) elements at the site.
Ensure compliance with global quality metrics and submit data to the QA Head and management on time.
Track and implement improvement objectives identified during quality metrics presentations.
Evaluate departmental efficiency and ensure cross-functional team members receive necessary training.
Assist the QA Head in implementing Electronic Quality Management System (E-QMS) modules for effective handling of QMS elements.
Investigate non-conformities (NCR/SNCRs), identify root causes, and implement effective Corrective and Preventive Actions (CAPA).
Review and approve Out of Specifications (OOS) results and ensure timely assessment for Field Alert Reports (FAR) or regulatory actions.
Ensure adequate investigation of Out of Trend (OOT), Out of Limit (OOL), and Laboratory Investigation Reports (LIR).
Review and approve Change Control Management (CCM) and Document Change Requests (DCR) as per Standard Operating Procedures.
Monitor and ensure that key performance indicators are maintained and achieved periodically.
Ensure data reliability and integrity.
Conduct site management reviews, NCR, OOS/OOT/OOL, and Change Control review meetings on time.
Attend CAPA review board meetings and monthly quality metrics review meetings as scheduled.
Support external and internal audits at the site, ensuring QMS compliance.
Communicate cross-functional requirements to concerned personnel and functions.
Periodically maintain and monitor the functional budget.
Support quality functions as required by the business.
Inform key management of critical quality-impacting QMS elements and raise concerns regarding potential deviations that may affect quality metrics.
What You'll Bring:
Strong understanding of QMS, CAPA, and compliance requirements.
Analytical mindset, attention to detail, and the ability to collaborate with cross-functional teams.
Ability to handle audits, monitor KPIs, and ensure compliance with established procedures.
Reasonable Accommodations:
Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you require assistance due to a medical condition or disability, please click here to provide your contact information and details.
Recruitment Fraud Notice:
Baxter has identified incidents of employment scams where fraudulent parties pose as Baxter employees to steal personal information. To protect yourself, review our Recruitment Fraud Notice.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
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