Job Title: IVPT QA Auditor
Location: Palava Phase 2, Dombivali East, Maharashtra
About Encube Ethicals:
Encube Ethicals Private Limited is a leading contract development and manufacturing organization (CDMO) specializing in topical dermatology products. We are committed to innovation, regulatory excellence, and delivering high-quality pharmaceutical solutions. Our state-of-the-art R&D Center is a hub of cutting-edge research and development, supported by world-class facilities and a dedicated team of professionals.
Summary:
Encube Ethicals is seeking a highly motivated and experienced IVPT QA Auditor to join our dynamic R&D team. In this role, you will be responsible for ensuring the quality and integrity of our In Vitro Permeation Testing (IVPT) studies, adhering to GLP principles, and maintaining compliance with regulatory standards. If you have a strong background in pharmaceutical quality assurance, a deep understanding of IVPT methodologies, and a commitment to data integrity, we encourage you to apply.
Responsibilities:
- Comprehensive IVPT Study Audits: Conduct thorough audits of IVPT studies from protocol to raw data, SAS datasets, and final reports, ensuring accuracy, completeness, and compliance with established procedures.
- Documentation Review: Review and approve analytical method validation and diffusion cell study documentation, ensuring adherence to regulatory guidelines and internal quality standards.
- Compliance Assurance: Ensure strict compliance with Good Laboratory Practices (GLP), ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), Quality Management Systems (QMS), and Data Integrity principles throughout the IVPT process.
- In-Process Audits: Perform in-process audits of ongoing IVPT studies to identify potential issues and ensure timely corrective actions.
- Deviation Management: Review investigations, deviations, change controls, and CAPA (Corrective and Preventive Action) effectiveness to ensure robust problem-solving and continuous improvement.
- Instrument Qualification: Oversee the instrument qualification process (IQ/OQ/PQ) for IVPT-related equipment, ensuring proper functioning and calibration.
- Regulatory Support: Support regulatory inspection readiness activities and host customer audits as required, representing the company’s commitment to quality and compliance.
Qualifications & Skills:
- Education: M.Sc / M.Pharm degree in Pharmaceutics, Pharmaceutical Analysis, or a related field.
- Experience: 2–3 years of hands-on experience in IVPT Quality Assurance (QA) or topical formulation QA within the pharmaceutical industry.
- IVPT Expertise: In-depth knowledge of IVPT methodology and practical experience in conducting and auditing skin permeation studies.
- Analytical Skills: Strong understanding of Liquid Chromatography-Mass Spectrometry (LCMS) and High-Performance Liquid Chromatography (HPLC) workflows in the context of topical drug analysis.
- Documentation Skills: Excellent documentation review and audit reporting skills, with the ability to clearly and concisely communicate findings and recommendations.
- Communication & Interpersonal Skills: Good communication and stakeholder management abilities, with the ability to effectively collaborate with cross-functional teams.
Benefits of Joining Encube Ethicals:
- Competitive Compensation: Attractive salary and performance-based incentives recognizing your contributions.
- Health & Wellness: Comprehensive health insurance and wellness programs to support your well-being.
- Global Exposure: Opportunity to gain experience with USFDA, EU, and other global regulatory audits, broadening your professional horizons.
- Career Development: Dedicated focus on career growth within a WHO-GMP & USFDA-approved facility, providing opportunities for advancement.
- State-of-the-Art Facilities: Work in a modern R&D center equipped with cutting-edge IVPT labs, enabling you to perform your best work.
How to Apply:
If you meet the qualifications and are excited about the opportunity to contribute to a leading pharmaceutical company, we encourage you to apply. Please submit your updated CV to [email protected] with the subject line: “Application for IVPT QA Auditor.”
Note: Only shortlisted candidates will be contacted for further evaluation.
We look forward to receiving your application!