QA for QC

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd in Hyderabad, India, seeks an experienced QA professional to oversee CM laboratory quality assurance and support regulatory inspections. You will coordinate CAPA, audit trails, and document reviews for analytical methods and SOPs, ensuring data integrity across dry product manufacturing.

The ideal candidate holds a BS in Life Sciences with 8+ years of GMP experience in pharmaceutical labs, and demonstrates advanced English proficiency to communicate with global teams

Qualifications

• 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.

Responsibilities

• 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.

Skills

QA oversight

GMP experience

Laboratory QA

Regulatory inspections

CAPA management

Data integrity

Documentation review

SOP approval

Education

Bachelor's degree in Life Sciences

Job description

Responsibilities

• 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.

Qualification & Expeirence

• 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.