Team Lead Drug Product
Job summary
We are looking for a meticulous professional to lead drug product manufacturing and sterile formulation operations ensuring adherence to Current Good Manufacturing Practice (cGMP) and safety norms. Your focus on drug product validation within defined timelines and volumes while maintaining compliance with quality standards and regulatory requirements is crucial to the organizations commitment to excellence in pharmaceutical production.
Roles & Responsibilities
You will be responsible for receiving inputs from production planning and preparing the monthly operation plan on the production floor encompassing scheduling staffing monitoring training and troubleshooting to ensure that all operations comply with applicable BPRs/EBRs (Batch Production Record/Electronic Batch Record) SOP (Standard Operating Procedures) and safety guidelines.
Your role involves understanding and administrating contract manpower supporting capacity supply and planning monitoring and controlling production schedules and preparing the annual production budget.
You will be responsible for reviewing and approving SOPs protocols reports discrepancies change requests CAPA (Corrective and Preventive Actions) QRM (Quality Risk Management) and batch and packaging records.
Your role will include collaborating with cross-functional departments to close discrepancies and implement corrective actions ensuring compliance with relevant GMP (Good Manufacturing Practices) safety standards and SOPs for designated manufacturing equipment.
Your role includes completing batch documentation in compliance with GMP collecting and maintaining data and participating/leading in quality and safety investigations to address and improve CAPA for drug product manufacturing & sterile formulation operation.
You will be responsible for maintaining manufacturing equipment for functionality and calibration compliance operating manufacturing equipment and automated systems within validated process parameters and actively promoting safety awareness and improvements.
You will engage in continuous improvement activities adhere to safety rules and report any unsafe matters or near misses/accidents.
You will be responsible for goal setting and performance reviews training and coaching employees effectively managing employee performance issues and corrective actions recognizing and appreciating employee contributions and undertaking activities to support the achievement of individual departmental and business objectives.
Qualifications :
Educational qualification: . . .
Minimum work experience: 8 to 10 years of experience in working with Biosimilar Products & sterile formulation operation.
Skills & attributes:
Technical Skills
Solid understanding of process manufacturing sterile formulation quality systems and the regulatory environment within the pharmaceutical or biopharmaceutical industry.
Expertise in cGMP principles and a strong knowledge of safety standards ensuring compliance with industry regulations.
Knowledge of biologics manufacturing processes emphasizing familiarity with the unique considerations and requirements of producing biosimilar products.
Expertise in formulation operations and sterile manufacturing showcasing knowledge of the specialized processes and stringent requirements in these areas.
Behavioural skills
Good listening and interpersonal skills fostering effective communication and collaboration within teams.
A keen eye for detail ensuring accuracy and precision in tasks and deliverables.
Sensitivity to deadlines managing time effectively to meet project timelines.
Ability to analyse situations and troubleshoot issues contributing to efficient problem-solving within the team.
Additional Information :
About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas covering US$80 Bn in innovator sales future business pipeline covers a variety of product classes and therapy areas and new modalities. Fully integrated organization with over two decades of experience in developing manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities in-house clone development upstream and downstream process development bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900000 patients having benefited from our products till date.
Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at Work :
No
Employment Type :
Full-time
Experience: years
Vacancy: 1