Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world's most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity, and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work.
Post : QA for QC – Dry External Manufacturing
Role Overview and Key Responsibilities
The Dry Product External Manufacturing QA Representative (QA for QC) provides quality assurance oversight of Contract Manufacturing Organizations (CM’s) laboratory operations, ensuring that analytical testing, data integrity practices, laboratory systems, and quality controls meet Lilly standards, cGMP requirements, and applicable regulatory expectations for CM’s involved with the manufacturing and packaging of solid oral dosage forms (e.g. tablets and capsules). The QA Representative is essential for ensuring that all testing meet specifications and analysed in accordance with validated practices. The role serves as a liaison between CMs laboratory operations and Lilly and is the initial point of contact for all quality-related laboratory issues at the assigned CM.
Key Objectives / Deliverables
• Serve as liaison between CMs and Lilly; provide quality oversight of CMs laboratory operations and acts as the initial point of contact for all laboratory related issues.
• Escalate quality issues at CMs to Lilly QA/QC management.
• Coordinate and perform QA responsibilities of lab sample shipments.
• Participate in regulatory inspection preparations with CMs; provide on-site support during inspections.
• Conduct routine review of CM laboratory practices through data integrity assessments, audit trail reviews, analytical instrument record review, and raw data traceability.
• Perform review and approval of documents including analytical testing methods, SOPs, method transfer and validation protocols, change control proposals, and analytical equipment qualifications.
• Oversee CM laboratory investigations (e.g. Out of Specification deviations) and CAPA management, providing QA review and approval of root cause analyses and effectiveness checks for laboratory originated events.
• Provide QA oversight of the dry product stability program, including review of stability protocols, data, and storage condition compliance at CM sites.
• Participate in Annual Product Review activities, Joint Process (JPT) teams, and Post Launch Optimization (PLOT) Teams.
• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
Candidate Profile
• Bachelor's degree (BS) in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
• At least 8 years of GMP experience, with experience in pharmaceutical laboratory quality assurance, quality control, or laboratory operations in a dry product or solid oral dosage form environment.
• Advance to proficiency English level.
• Thorough understanding of laboratory quality systems including OOS/OOT investigation requirements, method validation, method transfer, specification management, and regulatory requirements.
• Strong written and verbal communication skills; strong attention to detail.
• Ability to organize and prioritize multiple tasks; ability to influence diverse groups and manage relationships.
Additional Preferences
• Knowledge of analytical techniques common to solid oral dosage forms (e.g. HPLC, dissolution, particle size analysis, moisture analysis such as LOD and Karl Fisher, and physical characteristics testing such as hardness, friability, and disintegration.
• Knowledge regarding Specification and Materials/Supplier Management.
• Knowledge of pharmacopeia requirements (e.g. USP, Ph. Eur., and /JP).
• Experience reviewing and assessing laboratory data integrity controls, including audit trail review, system access controls, and raw vs. processed data traceability.
• Demonstrated knowledge regarding product stability and program oversight.
• Demonstrated coaching and mentoring skills.
• Proficiency with computer system applications (e.g. Darwin/LIMS, Empower, GPCMS, SAP, Trackwise, and Veeva QMS).
• Knowledge of pharmaceutical manufacturing operations.
• Excellent interpersonal and networking skills.
Additional Information
Experience : 5+ years
Qualification : Bachelor's Degree
Location : Hyderabad, Telangāna
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Dry External Manufacturing
End Date : 31st July 2026
QA Representative : Apply here
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Hyderabad Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
