Technical Documentation 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.

The ideal candidate for this position will succeed in this role if they have both knowledge and technical depth about the company and the industry. This is essential as they will be a central person in the decision-making process, working with multiple individuals across different teams when necessary. As a result, they will also be overseeing specific personnel.

Responsibilities

• Preparation and review of technical documents, Protocols and reports
• Review of Change control, CAPA, Effectiveness Checks, Events
• Handling of change control, deviations, CAPA Inco-ordination with QA department.
• Involving in the Investigate and closure of deviation.
• Management (Review and tracking) of annual refresher trainings.
• Preparation of User Requirement Specification (URS) for new machine.
• Preparation and review of Qualification documents for visual inspection machines.
• Responsible for procurement of new equipment in the inspection area by co-ordinating and discussing with vendors regarding the same.
• Preparation and review of risk assessment
• Review the SOP in File Netk
• Review of List of personnel, department organogram and Authorized Trainers lists
• Review of competency training for employees form annual inspection and automatic inspection machine)
• To monitor day to day inspection plan against production requirement and in compliance with the cGMP requirements
• Preparation of CAPEX & OPEX for the department.
• Adherence and maintenance of safety, health and environmental measures in area.
• Handling of activities related to Medical Devices.

Qualifications