Team Member - Sterile Operations

Job Description

Job summary
We are looking for an individual to perform filling/washing and sterilization operations within GMP (Good Manufacturing Practices), regulatory, and organizational guidelines. The objective is to produce products within defined volumes and timelines, ensuring compliance with quality standards, GMP, and regulatory requirements as per schedule.

Roles & Responsibilities
• You will be responsible for performing filling, washing, sterilization operations as per the day plan, executing batch production records, participating in filling area line clearance activities, and performing machine cleaning operations.
• Additionally, you will handle material dispensing and issuance from the warehouse.
• Your role also involves issuing discrepancies, working with cross-functional departments to close discrepancies, and implementing appropriate corrective actions.
• Compliance with GMP, safety standards, and SOPs (Standard Operating Procedure) for designated manufacturing equipment is crucial, and you are responsible for maintaining records in machine operation log books.
• You will play a key role in maintaining manufacturing equipment to ensure correct functionality and calibration compliance.
• You will actively engage in validation and qualification activities for all manufacturing area machines.
• Safety is a priority in your role, and you will actively promote safety awareness and improvements, engage in continuous improvement activities, and adhere to the company's safety rules.
• Reporting all unsafe matters, near misses, and accidents is an essential part of your responsibilities.

Qualifications

Educational qualification: A Diploma or B.Pharm.

Minimum work experience: 4 to 6 years of experience in batch formulation operations

Skills & attributes:

Technical Skills
• Proficiency in comprehending and overseeing sterile and fill finish operations in pharmaceutical manufacturing, demonstrating familiarity with the processes involved.
• Practical experience and hands-on knowledge in executing sterile and fill finish operations, showcasing the ability to actively participate in and manage these critical manufacturing processes.
• Practical expertise in equipment validation, process validation, and cleaning validation, demonstrating the ability to validate and ensure the reliability of manufacturing equipment and processes.

Behavioural skills
• Effective listening skills, ensuring a comprehensive understanding of information.
• A keen eye for detail, ensuring accuracy and precision in tasks.
• Awareness and sensitivity to deadlines, ensuring timely completion of tasks.
• Analytical skills and the ability to troubleshoot, enabling effective problem-solving.
• Strong interpersonal skills and the ability to work well in a team, fostering collaboration and positive team dynamics.

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 10–15-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 900,000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s 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. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t 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 we’re 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 https://careers.drreddys.com/#!/