Biocon Limited has announced a job opening for the following post.
Biocon Limited is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.
We are driven by the belief that the pharmaceutical industry has a humanitarian responsibility to provide essential drugs to patients who are in need and to do so with the power of innovation. In line with this belief, Biocon has developed and commercialized a differentiated portfolio of novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as, generic formulations in the U.S. and Europe. We are a leading global player for biosimilars and APIs for statins, immunosuppressants, and other specialty molecules, with customers in over 120 countries.
Title: Assistant General Manager
Department: Production Solid Orals
Qualification: B.Pharm/ M.Pharm
Experience: 12 Years to 18 Years
Salary: Not Disclosed
Roles and Responsibilities
- Manage the entire manufacturing and packaging operations of the solid dosage production facility.
- Responsible for production, planning, and scheduling activities. Prepare monthly production plan and deliver the products as per market requirement.
- Responsible for monitoring day to day operations towards the objective of continuously improving the performance metrics.
- Ensuring compliance with all internal and external, regulatory, and quality audits, processes, and systems inside the plant.
- Should be acquainted with operational excellence criteria.
- Coordinate with QA/QC/Planning/Engineering departments for the smooth functioning of the facility.
- Resource availability co-ordinations for raw material, Equipment SCM, Tooling, and Change part availability.
- Improve the plant efficiency, minimum machine breakdowns & continuous improvements.
- Provide strategic directions in investigating deviations, out of trend, and out of specification to suggest robust CAPA.
- Coordinate effectively across different functions to resolve a complex issue and drive new initiatives with concerted effort.
- Responsible to maintain EHS requirements and implementation of safety procedures.
- Responsible for the budget-related activities—Data availability (Capex, cost/unit, OH recovery, manufacturing efficiency, material usage. inventory controls, etc.)
- Detailed training on production documentation and data integrity.
- Identifying training needs, planning, and providing on job and SOP training to workers to optimize their performance at the shop floor for making them multi-skilled.
- Imparts skills on Shop floor activities & handling and balancing production lines by proper allocation of personnel, work, and resources in executives.
- Prepare and review of SOP’s, Batch Documents and related formats by regular following up regarding production planning, weekly, fortnightly, and monthly reviews.
Desired Candidate Profile
- Experience in manufacturing of solid dosage forms on large scale
- Mandatory potent facility exposure
- Knowledge of cGMP and regulatory guidelines
- Should have faced USFDA/ EU audits
- Should have experience in working with USFDA/ MHRA approved plant