Global Pharmaceutical Group (GNP) is a renowned leader in the pharmaceutical industry, with a strong presence through its key divisions: GNP (Global NAPI Pharma), GPI (Global Pharma Innovations), and GAP (Global Advanced Pharmaceuticals). Headquartered in India, the company specializes in manufacturing, research, and distribution of high-quality generic and innovative drugs, serving markets across Asia, Europe, and beyond. Committed to upholding the highest standards of GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), and GDP (Good Distribution Practice), Global Pharmaceutical Group ensures that every product meets stringent regulatory guidelines from bodies like the FDA, WHO, and CDSCO.
With a workforce of over 1,000 dedicated professionals, the company fosters a culture of innovation, integrity, and continuous improvement. Global Pharmaceutical Group invests heavily in employee development, offering training in QMS tools, audit preparedness, and regulatory compliance. As a forward-thinking organization, they prioritize work-life balance, competitive salaries, and opportunities for career advancement in the fast-evolving pharma landscape. If you’re excited about contributing to life-saving medications and regulatory excellence, joining GNP, GPI, or GAP could be transformative.
Job Description: Quality Assurance Senior Specialist
As a Quality Assurance Senior Specialist at Global Pharmaceutical Group, you will play a pivotal role in maintaining the integrity of our pharmaceutical operations. This position involves overseeing quality processes, ensuring compliance with global standards, and driving continuous improvement in manufacturing and documentation practices. Reporting to the Quality Assurance Manager, you’ll collaborate with cross-functional teams to mitigate risks, conduct audits, and prepare for regulatory inspections.
Key Responsibilities:
- Implement and monitor GMP, GLP, and GDP protocols to ensure product quality and safety across GNP, GPI, and GAP facilities.
- Manage QMS (Quality Management Systems) including CAPA (Corrective and Preventive Actions), deviation handling, and change control processes.
- Lead internal audits and support external regulatory inspections from agencies like USFDA, EMA, and Indian regulatory bodies.
- Review and approve batch records, stability studies, and validation documents to comply with regulatory guidelines.
- Investigate quality incidents, perform root cause analysis, and recommend problem-solving strategies to prevent recurrence.
- Train team members on quality assurance best practices and documentation standards.
- Stay updated on evolving pharmaceutical regulations and integrate them into company policies.
- Utilize MS Office and specialized documentation systems for reporting and data analysis.
This role demands a proactive approach to quality assurance in pharmaceuticals, where your analytical skills will directly impact product reliability and patient safety. With 3+ years of experience, you’ll thrive in a fast-paced environment focused on excellence.
Qualifications and Requirements:
- Bachelor’s degree in Pharmacy, Science, or a related field from a recognized university.
- Minimum 3 years of hands-on experience in quality assurance within the pharmaceutical or biotech industry.
- In-depth knowledge of GMP, GLP, GDP, and international regulatory guidelines (e.g., ICH, WHO standards).
- Proven experience with QMS software, internal/external audits, and regulatory inspections.
- Excellent analytical, problem-solving, and communication skills to handle complex quality issues.
- Proficiency in MS Office Suite (Excel, Word, PowerPoint) and electronic documentation systems like TrackWise or similar.
- Strong attention to detail, ethical mindset, and ability to work under pressure.
How to Apply for the Quality Assurance Senior Specialist Position
Ready to take the next step in your pharmaceutical career? Applying is simple and straightforward:
- Prepare Your Documents: Update your resume/CV highlighting your experience in GMP, GLP, GDP, QMS, audits, and regulatory inspections. Include your Bachelor’s degree details and any relevant certifications.
- Email Your Application: Send your resume, a cover letter explaining why you’re a fit for this Quality Assurance Senior Specialist role, and references to jobs@globalnapi.com. Use the subject line: “Application for Quality Assurance Senior Specialist – [Your Name]”.
