Pharmacy, Chemistry, Life Sciences Recruitment at Lilly

Lilly Hiring Details

• Post: QC Representative – Dry External Manufacturing
• Location: Hyderabad, Telangana
• Experience: 5+ years (At least 8 years of pharmaceutical Quality Control experience preferred)
• Qualification: Bachelor’s Degree in science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences or equivalent experience
• Industry: Pharma / Healthcare / Clinical research
• Functional Area: Dry External Manufacturing
• End Date: 31st July 2026

Role Overview & Key Responsibilities

QC Representative for Dry External Manufacturing provides quality laboratory oversight, assistance, and initial guidance to issues such as non-conformance investigations, change control proposals, method transfer, specifications, validations, and other duties associated with daily CM laboratory activities. Assures compliance to established quality policies, works with Joint Process Teams to maintain state of control in CM laboratories, integral for maintaining GMP compliance, supporting regulatory inspections, launching new products, processes, CMs. Specific focus laboratory activities oversight at CMs.

Key Objectives / Deliverables

• Review local procedures related to Lilly quality standards and provide redlines to ensure quality attributes met
• Support launch of new products, packages, CMs
• Provide technical leadership and project management oversight to drive improvements to CM laboratory quality systems
• Provide oversight to Dry External Manufacturing stability program, including protocols, studies, metrics, routine review of data
• Build and maintain strong working relationships with CM key personnel
• Support CMs in maintaining and improving quality systems, consulting with CM labs to understand Lilly lab quality requirements
• Provide initial consult guidance and quality oversight of manufacturing issues, deviations including OOS events, change controls, countermeasures
• Be change owner for analytical method, specification, or stability protocol revisions
• Review/approve lab GMP documents: testing methods, procedures, change controls, method transfer/validation protocols, analytical standards, stability data, reports
• Coordinate supply of reference standards to CM labs
• Support/oversee implementation of analytical method and specification change requests for labs supporting final product release testing
• Provide and coordinate sections including SPC and trend analysis of analytical data for Annual Reports and Annual Product Reviews
• Routinely conduct face-to-face and remote communications with CMs; execute SOP/methods assessments and track completion of outstanding issues

Candidate Profile

• Demonstrated relevant experience in GMP facility
• Technical understanding of cGMPs and Global Quality Standards
• Knowledge of pharmaceutical manufacturing operations, preferably dry products (capsules/tablets)
• Strong written and verbal communication, teamwork and interpersonal skills
• Ability to organize, prioritize, multi-task, influence diverse groups
• Strong decision making and problem-solving
• Technical knowledge of lab quality systems, methods, equipment
• Advance to proficiency English level

Additional Preferences

• Hands-on or oversight experience with HPLC, dissolution, particle size analysis, moisture analysis LOD and Karl Fisher, hardness, friability, disintegration
• Experience in electronic quality systems (Darwin/LIMS, GPCMS, Empower, SAP, Trackwise, Veeva QMS)
• Knowledge regarding Specification and Materials/Supplier Management
• Knowledge of pharmacopeia (USP, Ph. Eur., JP)
• Experience reviewing lab data integrity controls, audit trail review, system access controls, raw vs processed data traceability
• Knowledge regarding product stability and program oversight
• Project management, coaching, mentoring, stakeholder management skills

Apply Link

QC Representative – Apply Here