What are the responsibilities and job description for the Enzene - QC Lab Compliance Manager position at 1130.Works?
Job Description
About Our Client - Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.
Website: www.enzene.com
Position Overview
The Quality Control Lab Compliance Manager will focus on ensuring that laboratory operations meet regulatory standards and high-quality outputs, and be responsible for Stability and Sample receipt programs.
Key Responsibilities
Qualifications
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.
We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.
Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.
About Our Client - Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.
Website: www.enzene.com
Position Overview
The Quality Control Lab Compliance Manager will focus on ensuring that laboratory operations meet regulatory standards and high-quality outputs, and be responsible for Stability and Sample receipt programs.
Key Responsibilities
- Quality Control Oversight: Oversee laboratory processes and workflows to ensure they meet quality and compliance standards. Develop and manage Stability and Sample receipt programs.
- Equipment Management: Review equipment logbooks, audit trails, preventative maintenance and calibration of equipment.
- Handle Non-Conformities: Investigate and resolve any compliance issues which arise in the laboratories including OOS and deviations. Initiate change controls and implement CAPA as needed.
- Conduct Audits and Inspections: Perform regular audits and inspections of laboratory practices and documentation to ensure compliance with regulatory standards.
- Technology Transfer and Method Validation: Lead protocol/report writing and training. Support the execution in coordination with Lab Managers.
- Training: Review and maintain training records for the department. Identify training needs and design programs to enhance staff competency. Responsible for creating and maintaining department training curriculum in QMS.
- Team Leadership: Lead and train a team of lab compliance officers and technicians.
- Compliance: Stay updated on industry regulations and ensure that the laboratory complies with all relevant laws and standards.
- Data Analysis and Reporting: Review and analyse data related to lab operations and compliance to identify trends and areas for improvement. Prepare detailed reports on lab compliance activities including data integrity and present findings in department and global meetings.
Qualifications
- Education: Bachelor’s Degree in a relevant field such as Chemistry, Biochemistry, Biotechnology or a related field.
- Experience: Generally, 5-7 years of lab experience in analytical method development, validation, and transfer in the biopharmaceutical industry. 1-3 years of investigation and audit experience in compliance with regulatory standards.
- Skills: Proficient or knowledgeable in HPLC, UPLC, Gas Chromatography, Atomic Absorption, Mass Spectrophotometry, pH, CCIT, Water Testing (TOC), Karl Fischer, CIEF, CE-SDS, ELISA and other analytical methods. Skilled in LIMS /Veeva/TrackWise/Master Control.
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.
We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.
Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.
