Biocon - Senior Manager - DP Medical Device & Visual Inspection

Educational Background and Experience Required:.

- S/MBA or equivalent (preferably in Mechanical, Industrial or other Engineering background in IIT, NITTE, IIM's, Tier I Institution).

- 10-15 years of industrial experience, of which min.

- 5 years within multinational pharma/biopharma companies.

- Experience must include facing FDA, EMA, Anvisa, Health Canada, Australia.

- Project management skills, lean six-sigma (any belt).

Main mission.

- Alignment with BBL strategy and mission to provide affordable medicines to patients.

- Department lead should be able to lead and drive packing operations, ensuring best-in-class level performance, compliance and effective and standardized deployment of Lean six-sigma mindset and approach.

- Drive Medical Device department performance, ensuring implementation and optimal use of tools and data analytics.

Role/Job Description:

- People and up keeping of facility in anticipation and preparedness to face audit at any given point of time and scheduling of production activities for optimum utilization of resources in the production department.

- Quality of product is always met, by providing training and mentorship to team in following SOP's and other relevant documents of manufacturing processes(s), and develop KPI for packing department and root cause analysis on shopfloor and providing practical solution.

- Carry out all the activities in compliance and the cGMP requirements and as per GDP.

- Candidate must be able to trouble shoot issues by working with CFT's and closely work with Engineering maintenance team.

- Should be able to articulate well with CFT's and ensure tasks are completed on time.

- Should be able to handle a team of 30-40 members and manage multiple shifts.

- Candidate establish metrics for on-time delivery, compliance and training to safety, health and environment measures.

Technical / Functional Skills:

- Understanding of Visual Inspection (Manual & Automatic) and experience of cGMP, Qualification, Validation, 21 CFR.

- Understanding of pharma operations in an international and FDA-EMA regulated environment.

- Experience in medical device and having injectables experience is a plus.

- Any certifications such as ASQ is a plus.

Behavioral / Management / Others kills:

- Leadership, ability to foster mindset change, overcoming resistance and barriers.

- Record of successful cross-functional leadership.

- Persuasive and determined, able to convince multiple stakeholders and to handle complex situations.

- Ability to work under pressure and cope with multiple priorities.

- Excellent communication skills, up to ELT level and key external stakeholders.

- Strong analytical and problem-solving skills.