Manager

Rubicon Research Limited; Satara; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Rubicon Research Limited in Satara is seeking a Manager (Supervisor/Section In-Charge) for Quality Control with 11–15 years of experience.

You will lead a team of analysts and reviewers, ensure timely batch release, review raw data, and manage QMS activities including CAPA, investigations and audits.

Qualifications

• Bachelor's or Master's in Science/Pharma
• Experience leading a team of analysts and reviewers
• Hands-on experience with HPLC, GC, IR, UV, IC, KF, Dissolution
• Knowledge of data review and GLP/GMP compliance
• Experience in US-FDA/MHRA environments preferred
• Chromeleon software experience is advantageous

Responsibilities

• Lead a team of 10+ members (Analyst + Reviewer) for the section and release batches after analysis or tasks.
• Arrange review of analytical raw data for correctness and completeness for timely submission to QA.
• Handle QMS activities (incidences, investigations, file notes, ratification, OOS, OOT, Change Control, CAPA) and close within timelines.
• Ensure resources are available to smooth line functions and achieve deliverables with minimal support.
• Face audits (USFDA/MHRA/Client) for the section-related work.
• Demonstrate strong written and communication skills and execute tasks assigned by Sr. Leader.
• Adhere to GLP and Health, Safety Environment standards in the laboratory.

Skills

Team leadership

Data review

HPLC

GC

IR

UV

IC

KF

Dissolution

GLP/GMP knowledge

Education

Bachelor's or Master's in Science/Pharma

Tools

Chromeleon 7.2

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 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 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 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 Environment. requirement.