Job Description:

Position/Job Title:
Manager (Supervisor/Section In-Charge).

Department:
Quality Control

Reporting To:
Sr. Manager(P4)/AGM(M1)

Location:
Satara

Years of Experience:
11 to 15 years

Dosage Form:
Solid Oral/Liquid

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 functions 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 positive 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 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.

Additional notes:
Role is expected to work i

📌 Manager (Satara)
🏢 Rubicon Research
📍 Satara