Job Description
Purpose -To support Lab (Analytical) for maintaining Quality and compliance as per the GMP norms
Position / Job Title -Senior Executive
Department -Quality Assurance – Analytical Lab Quality Assurance
Reporting To -Manager.
Location -Ambernath
Years of Experience 8-10 Years
Dosage Form -Solid Oral / Liquid experience is must, Nasal & Injectables are preferred.
Job Responsibilities / Deliverables
Rubicon Research is a specialty pharmaceutical company focused on developing high quality products using innovative technologies for the global market.
Our Quality Systems, made up of policies, guidelines to ensure consistent product quality worldwide.
At Rubicon, teamwork, engagement, ownership, and support by everyone are vital for achieving our quality objectives.
Requirements For The JOB
- Well versed in the analytical review of documents, which includes of those from GLP section.
- OOS, OOT, Events, Change control, CAPA related QMS handling.
- Column management, Standard handling, glassware management, chemical management.
- Retention samples management and review of stability sample and study management.To review of stability protocol/summary sheet.
- Computer system validation, calibration & qualification of instruments. Review of audit trail from the computerized systems.
- Ensure QC laboratory compliance at all times, participate in Lab check rounds.
- Preparation & review of OOS/OOT/Events trending.
- Review of analytical documents, chromatograms related to AMT/AMV protocols and reports.
- Preparation of SOPs.
- To review the Analytical reports in support of Batch release activities.
- To review and approve the batches with generation of Certificate of Analysis for Finished Product.
- Review Analyst qualification data.
Qualifications & Pre-requisites
- Should be Graduate/Postgraduate in Science or Pharmacy
- Must have knowledge on handling HPLC, GC, KF, Dissolution. FTIR, FTNIR is preferable.
- Must have the exposure to LIMS.
- Having the expertise on computerized systems validation.
- Analytical instrument qualification knowledge is required.
- Exposure to various regulatory bodies like US FDA, MHRA, TGA.
- Exposure to specific dosage forms like OSD, Nasal / Injectables (preferred).
- Expertise in Qualification of CSV instrument documents verification.
- Expertise in Method validation and Analytical method transfer process.
- Exposure to expertise towards handling of QMS records.
Additional notes
- Role is expected to work in all shifts.
- Expected to visit Satara/Thane/Pithampur sites at least twice a month on need basis.
