Manager - Quality Control (Finished Products & Stability)

Rubicon Research; Mumbai, Ambernath; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Rubicon Research in Mumbai seeks a capable analytics team lead to head a 10+ member group (Analyst + Reviewer) and ensure timely completion of analyses, data review, and batch release. You will coordinate data reviews for QA submissions, manage QMS activities including CAPA, OOS, and Change Control, and oversee GLP compliance and audit readiness (USFDA/MHRA).

This role requires hands-on experience with instruments like HPLC, GC, IR, UV, IC, KF, and dissolution, plus strong written and verbal

Qualifications

• Bachelor or Master in Science or Pharmacy with relevant analytical experience.
• Proven experience leading a small to mid-size analytical team.
• Strong understanding of GLP, QA, and data integrity.

Responsibilities

• Lead a team of ~10+ analysts and reviewers to timely complete analyses and batch releases.
• Arrange reviews of analytical raw data for correctness and completeness for QA submissions.
• Handle QMS tasks including incidences, investigations, CAPA, OOS/OOT, and change control.
• Ensure resource availability to meet planning and deliverables with minimal supervision.
• Prepare for and face audits (USFDA/MHRA/client) related to the section.
• Maintain GLP and Health, Safety, and Environment compliance in the laboratory.

Skills

Team leadership

Data review

GLP knowledge

Audit readiness

Education

Bachelor/Master in Science/Pharma

Tools

HPLC

GC

IR

UV

IC

KF

Dissolution

Chromleon 7.2

Job description

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 skillsand 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 Environment. requirement.