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Manager-Product Quality and Responsible Complaint Person
2 weeks ago
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. Were looking for people who are determined to make life better for people around the world.
Manager- Product Quality and Responsible Complaint Person is responsible for: Manage Product Complaint:- Implement Product complaint process is in accordance with applicable GQS/GSOPs and local regulation for handling and managing product complaint.
- Coordinate all product complaints for India received externally and internally in compliance with local and global standard.
- Lilly marketed products counterfeit investigation coordinated with global security team and response to customers if required.
- Maintain the company complaint logs and monitor compliance with the local and global policies and applicable Quality agreements with external parties.
- Manage workflow using dedicated Quality Management Software.
- Responsible for timely reporting & closing of all product complaints in the software.
- Coordinate with PSP call center, supply chain and external partner, as applicable, the product complaint sample shipment for product quality investigation.
- Conduct PC reconciliation as applicable.
- Assist with the preparation of audits and inspections.
- Create statistical analysis of product complaint trends.
- Manage suspect counterfeit and tampered product reports according to applicable global procedure GSOP-130-4-TL-6, Suspect Product.
- To provide AE-PC training to employee (Internal and external network), PSP team, external parties and business partners.
- Consulting with the Associate Director-Quality Assurance regarding any significant quality issue in absence of PQR.
- Act as Primary Responsible Complaint Person (RCP) for India affiliate and North Africa affiliate.
- Assist the Sr. Manager-Product Quality in implementing the Quality Manual on Marketing Affiliates (CQP
- Finished product batches that meet all quality specifications and local regulations must be released.
- Manage Product Release in SAP system for consignment stock.
- Qualify shipment containers and perform temperature mapping as required for Controlled Room Temperature and Refrigerated products.
- Report immediately to the Associate Director - Quality Assurance of any suspected theft, tampering or other situations that could jeopardize any product quality, and its subsequent communication to Global Quality Leader and Local Management.
- Ensure that local customization is performed following the guidelines established by the quality area and according to global policies and standard operating procedures that apply local.
- Review the returned products, ensure that any potential quality issue or failure that could have originated the return will be reported appropriately and coordinate if new provision applies to these products (including medical samples).
- Assist Sr. Manager- Product Quality in preparation of Quality Agreement to be signed between the external party and local affiliate, coordinate the process of signatures as well as the periodic review of the agreement as provided in the corresponding global standards.
- Assisting in recall related activities as recall coordinator backup and primary owner of PQ BCP, Product complaint.
- Proficient in Microsoft Office, Veeva, and related tools.
- Strong technical writing skills.
- Knowledge of GDP, GSP, and applicable regulatory guidelines.
- Effective interpersonal and communication skills (internal & external).
- Ability to train teams and work independently.
- Strong problem-solving and analytical abilities.
- Fluent in English (spoken, written, and reading).
- Required to be in office 4 days a week.
- Bachelors or Master degree in Pharmacy, Pharmaceutical Chemistry, or equivalent (locally recognized).
- 24 years of quality-related experience in the pharmaceutical or allied industries.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLillyLocations - LocationGurgaon, Haryana, India
