We are seeking an experienced Quality Assurance (IPQA) professional to ensure compliance with operational, regulatory, and global standards. This role entails real-time monitoring, investigating deviations, and maintaining adherence to defined processes, ensuring smooth manufacturing and testing operations.
In-Process Activities:
Execute or assign in-process activities during shifts.
Conduct line clearances, material verification, and oversee machine start-ups.
Coordinate sampling activities to ensure quality and compliance.
Documentation:
Execute or assign the execution of batch records and logbooks.
Fill and review various formats, including line clearance, sampling formats, and batch record review sheets.
Ensure online documentation and adherence to incident reporting systems for deviations.
Procedures and Quality Systems:
Ensure the availability, issuance, and adherence to approved procedures for the manufacturing team.
Verify compliance with Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions).
GMP Compliance:
Confirm adherence to Good Manufacturing Practices (GMP) at all times.
Monitor facility upkeep, environmental conditions, segregation of materials, and proper labeling.
Follow incident management processes for deviations.
Investigations and CAPA:
Support investigations related to complaints, batch failures, and OOS/OOT results by gathering data and conducting interviews.
Collaborate with cross-functional teams to perform root cause analyses, document CAPAs, and monitor their effectiveness.
Audits:
Assist with internal and external audit activities by providing necessary information and documentation.
Follow up with departments to share audit responses and track the closure of action items.
B. Pharm or Post-Graduation in Life Sciences.
Minimum 4 years of industrial experience in Quality Assurance (IPQA).
Technical Skills:
Proficiency in Quality Systems and organizational functions.
Knowledge of Bio Pharma and Pharma markets, including regulatory frameworks and market dynamics.
Familiarity with global cGMP requirements (FDA, EU, Indian authorities).
Understanding of pharmaceutical products, manufacturing processes, and quality standards.
Ability to implement organizational policies and ensure compliance.
Behavioral Skills:
Commitment to continuous learning and improvement.
Strong communication and influencing abilities.
Analytical and logical thinking.
Self-motivation and initiative.
Adaptability and teamwork.
Innovative and proactive approach.
Benefits Offered:
At Dr. Reddy’s, we support your career growth through personalized learning programs and benefits that meet industry standards.
Our Work Culture:
Guided by the credo, "Good Health Can’t Wait," our culture promotes excellence and dedication to health and well-being.
For more details, please visit our careers website: Dr. Reddy’s Careers
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