Analytical Science & Technology (AS&T) Expert - Quality Operations
Job ID: REQ-10013372
Posted On: September 3, 2024
Location: Hyderabad, India
Job Summary
The AS&T Expert in Quality Operations plays a key role in overseeing and managing analytical activities for commercialized pharmaceutical products. This role is crucial in providing scientific analytical support to ensure compliance with regulatory standards and operational excellence.
Key Responsibilities
- Oversee and manage the transfer of analytical methods and stability studies. Compile and analyze data reports.
- Develop and maintain Quality Control monographs, ensuring proper test procedures and specifications.
- Provide scientific support for quality control, production, regulatory affairs, and marketing teams.
- Present and discuss analytical findings with local and international project teams.
- Manage the lifecycle of analytical methods, including performance monitoring, pharmacopoeia compliance, and regulatory adherence.
- Investigate deviations, out-of-specification (OOS), out-of-trend (OOT), and out-of-expectation (OOE) cases.
- Serve as a key interface between Manufacturing Science & Technology, analytical development, production, and regulatory departments.
- Coordinate analytical activities conducted at external laboratories (CROs) and support troubleshooting and continuous improvement initiatives.
- Ensure implementation of Good Manufacturing Practices (GMP) and compliance with analytical protocols, performance reports, process verification reports, and registration documents.
- Manage budgeting and cost control for external analytical operations.
- Participate in QC/AS&T network teams and oversee the management of reference substances and control samples.
Essential Requirements
- At least 10 years of experience in the pharmaceutical industry or analytical laboratories operating in a GMP-compliant environment.
- Proficiency in MS Office and other standard IT applications.
- Strong communication and collaboration skills to interact effectively within both local and global teams.
- Proactive mindset with a focus on continuous improvement and innovation.
- Ability to adapt quickly to changes and challenges while maintaining analytical precision.
- Expertise in analyzing complex processes and problem-solving.
Preferred Qualifications
- A degree in Chemistry, Pharmacy, Biology, Engineering, or a related scientific field.
- Proficiency in English (German language skills are an advantage).
Why Join This Opportunity?
This position offers an opportunity to contribute to groundbreaking pharmaceutical advancements aimed at improving global healthcare. By joining, you become part of an organization dedicated to innovation, quality, and continuous professional development.