Senior Quality Assurance Manager
4 weeks ago
At Athenese Dx Private Limited, we are seeking a highly skilled and experienced Sr. QA Executive to join our team.
Job Summary:The Sr. QA Executive will be responsible for supporting various aspects of quality management, including document control, compliance monitoring, internal audits, quality metrics tracking, and non-conformance management.
Key Responsibilities:- Document Control: Assist in maintaining and organizing quality documentation, including Quality Manual, Documented Procedures, Standard Operating Procedures (SOPs), and forms.
- Internal Audits: Participate in internal audits of various departments to assess compliance with the Quality Management System (QMS) and report findings to senior QA staff.
- Non-Conformance Management: Support the investigation of non-conformities or deviations, aiding in root cause analysis and the development of corrective and preventive actions (CAPAs).
- Change Control Support: Assist in the change control process, including reviewing change requests and assessing their potential impact on quality and compliance.
- Risk Management Assistance: Collaborate with senior QA staff in performing risk assessments and assisting in the implementation of risk management strategies.
- Product and Process Validation Support: Participate in product and process validation activities, ensuring that they meet specified requirements.
- Complaint Handling Support: Assist in the review and resolution of customer complaints related to product quality.
- CAPA Support: Support CAPA processes by helping to gather data and track the progress of corrective actions.
Requirements:
- Bachelor's / Master's degree in life science background.
- 2 to 4 years of relevant experience preferred in a similar role in IVD industry.
What We Offer:
A competitive salary and benefits package, as well as opportunities for professional growth and development.
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