Assistant Manager

Biocon Biologics

is a fully integrated ‘pure play’ biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe.

Responsibilities

Requisition and receiving BMR (Additional Page) and batch related execution checklists.

Receiving document number / effective date for technical documents, Protocols and reports.

Preparation, issuance and archival of logbooks

Preparation and revision of technical documents, Protocols and reports.

Receiving technical documents, Protocols, reports and SOP copies, IOC

Entering of all the logs and documents related to visual inspection area.

Reviewing of all completed logbook and arranging them in document storage.

Responsible for the verifying all executed document BMR, Initiation and Review of Change control, CAPA, Event

Responsible for tracking (CFT review, approval and completion / closure) of Change control, CAPA, Event Initiation of extension

Handling assigned Change control, CAPA, Event for closure

Handling of change control, deviations, CAPA in coordination with QA department.

Involving in the Investigate and closure of deviation.

Adherence to cGMP (Current Good Manufacturing Practices).

To Adhere to the Good hygiene practices and reporting to illness and other unhygienic incidents

Adherence to Good documentation practices.

To implement Quality Measurements as per GMP

Qualifications

Bachelor’s or master’s degree in pharmacy ,

Life Sciences, Biotechnology, Chemistry, or B.Tech or M.Tech related discipline.

8+ years of retail or equivalent management experience

Strong verbal or written communication skills