Position / Job TitleGeneral Manager/Asst General Manager (Leader + Section In-Charge) DepartmentQuality Control Reporting ToAVP (M4)LocationAmbernath Years of Experience18 years +Dosage FormSolid Oral / Nasal / Liquid Job Responsibilities / Deliverables

- Responsible for leading the QC team size of 40+ Members with good leadership qualities to achieve company goals. He should have sound analytical knowledge and expertise in all types of modern analytical instruments like HPLC, GC, IC, PSD etc. He should have the capability of problem solving for team.
- Overall responsible for Analytical method validations/verification and transfers i.e to ensure completion of Analytical method validations/verifications/transfers in timely and compliant manner. Responsible for initiation, execution & approval of all incidents, investigations, File notes, ratification, OOS, OOT, Change Control, Deviations, CAPA etc.

- Secondary responsible for back up support to the QC HOD with daily update, commercial output, monthly sample status, Training, monthly review meeting and co-ordination with all QC site for work output
- Also responsible for leading any type of automation project (Eg. Lab-Automation) in Lab and actively participate to success it with ownership.
- He should be self-driven, have the capability to take self-decision and be a good learner.



He should have the capability to lead all types of QC work in the absence of QC-HOD and actively participate in departmental improvement programs to enhance the Output and Quality.
- He should have experience of new lab set up.
- He should have experience of facing the FDA Audit (US, MHRA, EU) individually.
- Responsible for adherence of GLP and Health, Safety Environment system in Laboratory.
- Should have positive written and communication skill and perform the task given by the HOD as and when required.

Qualifications & Pre-Requisites Preferably have following skill but not limit as mentioned below.

- Master Degree of Science / Bachler or Master Pharma.
- Good knowledge of HPLC / Dissolution / GC / IC / IR / Water by KF.
- Responsible for ensuring completion of GLP and QMS activities.
- Knowledge of Chromeleon 7.2 software will be an added advantage.
- Should have good working experience in GMP and USFDS/EU Audit faced.
- Should have skill to achieve deliverable task with minimum support for analysis.

Additional Notes

- Role is expected to work in all shifts.
- If required he might need to travel to Satara, Thane site, on work priority as per company policy.
- Responsible for ensuring compliance to GLP, Health, Safety and Environment.

📌 Assistant General Manager (Ulhasnagar)
🏢 Rubicon Research
📍 Ulhasnagar