Manager
Job Description
Position / Job Title
Manager (Supervisor / Section In-Charge).
Department
Quality Control
Reporting To
Sr. Manager / AGM
Location
Chhatrapati Sambaji Nagar
Years of Experience
11 to 15 years.
Dosage Form
Solid Oral / Nasal / Liquid
Job Responsibilities / Deliverables
Responsible for leading the team of Approx 10+ members for Stability section and handling all stability sample flow including sample charging, schedule, documentation (protocol/report/data sheet), chamber maintenance and report submission 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 departments as per specified timelines.
He is responsible for QMS handling (incidences, investigations, File notes, ratification, OOS, OOT, Change Control, CAPA etc.) as per requirements 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 good experience of team handing for stability section including stability management. He should have past analytical experience of modern instruments like HPLC, 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.