Farbe Firma Pvt. Ltd.
Website:
farbefirma.org
Job details:
Company Description Farbe Firma Pvt. Ltd. is a WHO-GMP certified pharmaceutical manufacturer based in Ankleshwar, Gujarat, India, specializing in sterile injectable formulations for global markets. The company produces a broad range of injectable products, including lyophilized vials, liquid-filled vials and ampoules, small volume parenterals, and critical care injectables across multiple therapeutic areas. Farbe Firma operates as a trusted CMO/CDMO partner, offering contract manufacturing, contract development, branded generics, private label solutions, and regulatory support for international registrations. Its state-of-the-art facility features advanced lyophilizers and aseptic filling lines to ensure high levels of sterility and product quality. The organization is dedicated to making high-quality, affordable injectable medicines accessible worldwide, serving pharmaceutical companies, distributors, and healthcare providers in over 50 countries.
Role Description The QA Manager will oversee the quality assurance function for sterile injectable manufacturing, ensuring compliance with WHO-GMP and other applicable regulatory standards. This full-time, on-site role in Ankleshwar involves developing and implementing QA systems, SOPs, and documentation practices; managing batch record review and product release; and driving continuous improvement in quality processes. The QA Manager will coordinate internal and external audits, handle deviation, CAPA, and change control management, and collaborate closely with production, QC, regulatory, and engineering teams to maintain product quality and sterility assurance. The role also includes training and mentoring QA staff, monitoring quality metrics, and supporting regulatory submissions and customer audits.
Qualifications
- Strong expertise in pharmaceutical quality systems, including WHO-GMP, cGMP, and regulatory compliance for sterile injectables.
- Hands-on experience with aseptic manufacturing processes, lyophilization, sterile filling, and environmental monitoring.
- Proficiency in documentation control, batch record review, deviation investigations, CAPA, and change management.
- Demonstrated ability to manage audits and inspections, including internal audits, regulatory audits, and client quality audits.
- Solid understanding of validation and qualification activities (process validation, cleaning validation, equipment qualification).
- Excellent analytical, problem-solving, and decision-making skills, with attention to detail and risk-based thinking.
- Effective leadership and people management capabilities, including team mentoring, training, and cross-functional collaboration.
- Clear written and verbal communication skills for technical reporting, SOP writing, and stakeholder interaction.
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Microbiology, Chemistry, or a related discipline.
- Previous experience (typically 5–8+ years) in QA roles within injectable or sterile pharmaceutical manufacturing is highly preferred
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