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Quality Assurance Maintenance Specialist
2 meses atrás
Join Dr. Reddy's: A Commitment to Health
At Dr. Reddy's, we are dedicated to transforming healthcare by making essential medicines accessible and pioneering innovative treatment solutions. Our mission is to empower individuals to lead healthier lives, and we invite passionate and proactive individuals to join us in this endeavor.
Our Commitment to Diversity and Inclusion
We believe in fostering a diverse, equitable, and inclusive workplace where every team member is valued for their unique contributions. We are focused on finding the most suitable candidate for the role, welcoming applicants from various backgrounds.
Key Responsibilities:
This role encompasses responsibilities across several functional domains, including Facilities Management, Warehouse Operations, Quality Control, and Quality Assurance, ensuring adherence to policies, Standard Operating Procedures (SOPs), and compliance with current Good Manufacturing Practices (cGxP) and current Good Laboratory Practices (cGLP).
- Oversee the comprehensive maintenance of laboratory and warehouse facilities, including regular qualification of all areas and equipment, such as HVAC systems and Electric Generators;
- Stay informed about regulatory requirements and cGxP/cGLP standards relevant to the role;
- Manage projects and routine maintenance/qualification processes, from User Requirement Specification (URS) preparation to vendor selection and proposal analysis for final approvals, ensuring completion and certification of activities;
- Ensure preventive and corrective maintenance of analytical instruments across all laboratories;
- Maintain accurate records of all QC lab analytical instruments and warehouse devices in the ERP system, collaborating with Quality IT and QA for cGxP documentation;
- Update the preventive maintenance schedule to reflect new instruments or calibration timelines;
- Create and maintain task lists for all analytical and warehouse equipment in the ERP system;
- Conduct preventive maintenance and performance monitoring as per the established schedule, ensuring all documentation is traceable and compliant;
- Close out preventive maintenance orders in the ERP system post-completion;
- Generate notifications for breakdown maintenance based on received requests;
- Ensure instruments and equipment are utilized according to relevant SOPs, updating or creating SOPs as necessary;
- Close breakdown notifications or orders after maintenance is completed;
- Manage inventory of necessary spare parts and services for all instruments and equipment, ensuring contracts are current;
- Initiate change controls as required;
- Fulfill additional responsibilities as assigned by the Group Leader;
- Coordinate vendor visits and ensure compliance with safety protocols in laboratory and warehouse settings.
Qualifications:
- Bachelor's degree in Engineering (Civil, Mechanical, or Electrical);
- Proven experience in building and equipment maintenance planning and execution, particularly within the pharmaceutical sector;
- Intermediate proficiency in English, including conversational skills.
Essential Soft Skills:
- Hands-on and collaborative approach;
- Strong interpersonal and communication abilities;
- Adaptability to diverse environments;
- Networking capabilities;
- Strategic and analytical thinking;
- Effective planning and organizational skills;
- Ability to collaborate with cross-functional teams globally;
- Persistence in managing both short and long-term projects.
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