6 дней назад
Quality Associate III
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Associate III (Analytical Quality Assurance): Ensuring analytical laboratory activities, data, and documentation meet global quality and regulatory requirements with an accent on GMP/GLP compliance, data integrity, and product registration support. Focus on reviewing method validation and stability studies, leading OOS/OOT and data integrity investigations, and maintaining audit readiness across analytical systems and laboratories.
Location: Bangalore, Karnataka, India
Company
develops vital organ therapies, digital solutions, and advanced services focused on improving kidney care and patient outcomes.
What you will do
- Provide quality assurance oversight for internal and external analytical laboratories.
- Review and approve analytical method validation, method transfer, stability, extractables and leachables, specifications, test methods, and certificates of analysis.
- Review and approve OOS, OOT, deviation, incident, and data inconsistency investigations.
- Ensure analytical activities comply with GMP, GLP, ALCOA+ data integrity principles, and global registration requirements.
- Oversee laboratory systems and data tools, including LIMS and ELN, while identifying and mitigating data integrity risks.
- Support audits, health authority inspections, CAPA reviews, management reviews, CRO investigations, SCARs, and product lifecycle records.
Requirements
- 10+ years of experience in analytical chemistry and/or quality assurance, including 4–6 years overseeing analytical quality functions.
- Strong knowledge of analytical techniques including HPLC, GC, spectroscopy, dissolution, impurity profiling, and stability studies.
- Experience with method validation, method transfer, analytical equipment qualification, and extractables and leachables or related studies.
- Deep understanding of GMP, GLP, ICH guidelines, global pharmacopeias, and FDA regulations.
- Strong analytical, problem-solving, communication, influencing, and negotiation skills.
- Demonstrated ability to lead others in small projects or investigations and support regulatory submissions and product registrations.
Culture & Benefits
- Mission-driven work focused on extending lives and improving patient and care-team outcomes.
- Collaboration with quality, regulatory affairs, laboratory, and cross-functional teams.
- Participation in global audits, health authority inspections, and product registration activities.
- Reasonable accommodations are available for individuals with disabilities during the application and interview process.
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