Join Our Team as a Specialist Product Quality!
We are a leading pharmaceutical company committed to excellence in product quality and innovation. Currently, we are seeking a motivated Specialist Product Quality to join our dynamic team. This role offers an exciting opportunity to contribute to the development and maintenance of GMP documents and product stability studies, ensuring compliance and advancing our mission to deliver high-quality pharmaceutical solutions
Key Responsibilities:
- Develop and maintain technical GMP documents and oversee product stability studies
- Review, verify, report, and archive GMP data for clinical and commercial products
- Conduct rigorous data analysis and prepare detailed reports with meticulous attention to accuracy
- Execute transactions within GMP computer-based systems such as LIMS and manage associated documentation
- Independently manage time-sensitive activities critical to quality assurance processes
Top Technical Skills Required:
- Expertise in stability study design and implementation
- Proficiency in data analysis techniques to derive meaningful insights
- Strong technical writing skills for documenting procedures and findings
- Previous experience in GMP or pharmaceutical settings
- Familiarity with MS Office suite (Excel, Word, Project), LIMS, and document management systems
Experience and Education:
- Doctorate degree OR Master’s degree with 3 years of relevant experience OR Bachelor’s degree with 5 years of experience OR Associate’s degree with 10 years of relevant experience OR High school diploma/GED with 12 years of experience
- Preferred background in chemistry, biochemistry, biology, or related pharmaceutical sciences
- Experience in a regulated environment (GMP) and familiarity with international filing regulations
Preferred Qualifications:
- Track record in managing synthetic or biological stability programs
- Strong project management capabilities and cross-functional team collaboration experience
- Understanding of biologic and synthetic pharmaceutical manufacturing processes
- Excellent verbal and written communication skills for effective interaction with stakeholders and regulatory bodies
Day-to-Day Responsibilities:
- Oversee and maintain stability studies within our quality systems, ensuring data integrity and compliance
- Lead the documentation and submission of product quality and stability data for regulatory filings
- Support site-based GMP inspections and contribute to continuous improvement initiatives
- Contribute to SOP development and ensure adherence to regional regulatory requirements
- Collaborate closely with cross-functional teams to drive quality and operational excellence
If you are passionate about ensuring product quality in a regulated environment and possess the required skills and experience, we invite you to apply for this rewarding opportunity. Join us in advancing pharmaceutical excellence and delivering impactful solutions to global healthcare challenges
About SSi People:
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.