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Sr. Manager- Product Quality

3-5 years
Not Disclosed
10 Dec. 17, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Assurance Manager - Lilly India Affiliate and Nepal
Location: Gurgaon, India
Job Type: Full-time

Scope of the Position:
At Lilly, we unite caring with discovery to make life better for people around the world. We are seeking a Quality Assurance Manager for our Lilly India Affiliate and Nepal to ensure the quality and compliance of our pharmaceuticals throughout the supply chain. The successful candidate will work cross-functionally with various departments and ensure adherence to Good Distribution Practices (GDP) and other regulatory standards.

Responsibilities:

  • Ensure compliance with Good Distribution Practices (GDP) and other regulatory requirements throughout the supply chain.
  • Collaborate with departments such as Regulatory Affairs, Supply Chain, Pharmacovigilance, and affiliate management.
  • Proactively identify and mitigate quality risks, collaborating with relevant teams to implement corrective actions.
  • Resolve quality-related issues or complaints promptly and escalate as needed to minimize impact on operations.
  • Conduct regular audits and inspections of warehouses to ensure compliance with quality and regulatory standards.
  • Provide support for product complaints collection and management.
  • Offer training and guidance on quality standards, procedures, and regulations to external parties and cross-functional teams.
  • Maintain documentation in line with Good Documentation Practices and ensure data integrity, with readiness for audits at any time.

Requirements:

  • Bachelor’s degree in pharmacy or life sciences (postgraduate degree is a plus).
  • 3-5 years of experience in Quality Assurance (Regulatory experience is a plus).
  • Experience in warehouse auditing.
  • Strong knowledge of Good Distribution Practices (GDP) and Indian regulations related to Quality Assurance.
  • Ability to travel frequently within India (20-30% of the time).
  • Strong communication skills, both written and verbal, to convey complex information clearly to stakeholders.
  • Strong organizational and time-management skills with the ability to handle multiple priorities.

Lilly Overview:
Lilly is a global healthcare leader based in Indianapolis, Indiana, committed to discovering and bringing life-changing medicines to those who need them. Our employees work to improve the understanding and management of diseases and give back to the communities through philanthropy and volunteerism. At Lilly, we are passionate about our mission and put people first.