12 Oct
|
Rubicon Research
|
Mumbai
12 Oct
Rubicon Research
Mumbai
Role & responsibilities
- Responsible for leading the team of Approx 10 members (Analyst Reviewer) for respective section and release the batches after completion of analysis or any other given task as per target completion date.
- Responsible for arranging a review of analytical raw data for correctness and completeness and to ensure final data submission to QA or other respective department as per specified timelines.
- He is responsible for QMS handling (incidences, investigations, File notes, ratification, OOS, OOT, Change Control, CAPA etc.) and closing within stipulated timeline with proper root cause of his section.
- To ensure and arrange all resources available to smooth line function as per planning and achieve deliverable task with minimum support.
- He is responsible for facing the Audit (USFDA/MHRA/Client etc.) with respective section related work.
- Should have good written and communication skills and perform the task given by the Sr. Leader as and when required.
- Responsible for adherence of GLP and Health, Safety Environment system in Laboratory.
Preferred candidate profile
Preferably have following skill but not limitas mentioned below;
- Bachelor / Master Degree of Science / Pharma.
- He should have good experience of team handing (Analyst Reviewer) for respective section. He should have past analytical experience of modern instruments like HPLC, GC, IR, UV, IC, KF, Dissolution etc. and requires knowledge of data review.
- He should have experience of QMS Handling and know about GLP-GMP standard of analytical work.
- The candidate having experience in US-FDA/MHRA approved company is preferable.
- Knowledge of Chromleon 7.2 software will be an added advantage.
- Role is expected to work in all shifts.
- If required, the candidate should be ready to travel to all plant locations on work priority as per company policy.
- Responsible to ensure compliance to GLP, Health, Safety and Workplace. requirement.
Role: Quality Assurance - Other, Industry Type: Pharmaceutical & Life Sciences, Department: Quality Assurance, Employment Type: Full Time, Permanent Role Category: Quality Assurance - Other Education UG: B.Pharma in Any Specialization PG: M.Pharma in Any Specialization, MS/M.Sc(Science) in Organic Chemistry, Chemistry read more
Key Skills Skills highlighted with ‘‘ are preferred keyskills Stability AnalysisFinished ProductsQuality Control GLP
📌 Manager - Quality Control (Finished Products & Stability) (Mumbai)
🏢 Rubicon Research
📍 Mumbai