02 Oct
|
Rubicon Research
|
Indore
02 Oct
Rubicon Research
Indore
Job Description:
Job Description
Position / Job Title - Assistant Manager (Sub Supervisor / Section In-Charge).
Department - Quality Control
Reporting To - Sr. Manager (P4) / AGM (M1)
Location- Pithampur
Years of Experience - 11 to 15 years.
Dosage Form - Solid Oral
Job Responsibilities / Deliverables
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.
Qualifications & Pre-Requisites
Preferably have following skill but not limit as mentioned below;
Bachelor / Master Degree of Science / Pharma.
He should have valuable 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.
Additional notes
Role is e
📌 Assistant Manager (Indore)
🏢 Rubicon Research
📍 Indore