Executive / Sr. Executive - Analytical Quality Assurance
Bengaluru, Karnataka, India · Tempo total
Seja o primeiro a se candidatar
- Experiência
- 5–10 yrs
- Salário
- INR 400,000 – INR 750,000 / year
- Vagas
- 1
- Publicado
- há 12 horas
- Modo de trabalho
- No escritório
- Educação
- M.Sc / M.Pharmacy
- Elegibilidade
- Candidates with a Bachelor of Pharmacy (B.Pharma) in any specialization are eligible to apply.
- Retomar
- Obrigatório candidatar-se
Onde você trabalhará
Descrição da vaga
About Meyer Organics
Founded in 1982, Meyer Organics is a key part of Vitabiotics Ltd, the world's leading and fastest-growing nutraceutical company headquartered in London with operations in 110 countries. Vitabiotics is renowned for its commitment to scientific research in nutrient medicine, earning the prestigious UK's Queens Award for Excellence and Innovation in Vitamin Research for three consecutive years. Meyer Organics has been dedicated to producing pioneering healthcare products for over 30 years across segments including anti-infectives, nutritional supplements for various age groups, infertility supplements, and pain management solutions.
Role and Responsibilities
- Conduct audits of laboratory data, including validation of raw analytical data and electronic chromatograms (UV, FTIR, AAS, HPLC, GC), and review computerized system audit trails to ensure adherence to ALCOA++ data integrity standards.
- Review batch releases by cross-verifying final lab outcomes and Certificates of Analysis against product specifications before granting batch approval.
- Manage Good Laboratory Practices (GLP) through handling out-of-specification (OOS), out-of-trend (OOT) results, deviations, incidents, CAPA, change controls, and maintaining their logs daily.
- Supervise validation processes by reviewing and approving analytical method validation protocols, verifications, instrument qualifications (IQ/OQ/PQ), and compliance with 21 CFR Part 11.
- Maintain control of quality documents including QC SOPs, standard testing procedures, and product specifications.
- Ensure the laboratory is always prepared for stringent regulatory inspections by maintaining continuous compliance.
- Conduct internal QC audits, handle and close laboratory incidents and occurrences through thorough investigation and resolution.
- Analyze trend data regularly and communicate critical quality issues to senior management.
- Review external laboratory reports and ensure compliance as per technical agreements.
- Evaluate stability reports and data, escalating key quality concerns to higher authorities.
- Guarantee adherence to Environmental Health and Safety (EHS), hygiene, and environmental standards within the QC laboratory, maintaining GLP requirements.
Preferred Candidate Profile
- Educational Qualification: M.Sc or M.Pharmacy.
- Experience: 5 to 10 years in the pharmaceutical industry.