DGM/Sr. Manager - Development Quality Operations SUN PHARMA

10.0 - 14.0 years

0 Lacs

haryana

On-site

As a Technical and Scientific Leader in upstream processes for early-stage development, you will play a crucial role in ensuring the seamless handover of Suns Branded Portfolio products from development to commercialization. Your responsibilities will include providing quality input into CMC strategy, representing quality oversight in various stages of process development, and contributing to the planning of Clinical trial materials. You will also collaborate with cross-functional teams to facilitate a smooth transition to Commercial QA and manufacturing. Your scientific leadership will be instrumental in supporting process and product investigations, troubleshooting issues, and identifying opportunities for improvement. You will be expected to leverage your technical expertise to oversee experimental planning, analyze development results, and review manufacturing data. Additionally, you will be responsible for authoring and reviewing CMC documentation for regulatory filings, as well as providing support during health agency inspections. In order to excel in this role, you must possess an MS or PhD in chemical/biochemical engineering, biochemistry, or a related field, along with a minimum of 10 years of relevant experience. A proven track record of technical manufacturing experience, the ability to drive technical quality rigor, and strategic analysis skills are essential. Your capacity to manage multiple projects in a fast-paced environment, utilize risk-based decision-making approaches, and work collaboratively in a matrix environment will be critical to your success. Furthermore, your strong interpersonal skills, effective communication abilities, and demonstrated project management capabilities will be valuable assets in this role. Experience with audits in global regions and the flexibility to travel to the US and/or EU countries will be advantageous. If you are looking to join a dynamic Development Quality team and contribute to the advancement of Suns Branded Portfolio products, this opportunity may be the perfect fit for you.,

Posted 1 day ago

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Validation Testing Impetus Career Consultants

3.0 - 7.0 years

0 Lacs

pune, maharashtra

On-site

You should have knowledge of regulatory standards such as GxP and FDA 21 CFR Part 11. It is essential to collaborate effectively with developers and stakeholders to proactively understand and analyze the application requirements. Your responsibility will include creating comprehensive test cases and scenarios based on risk-based approaches, with a specific focus on critical functionalities and compliance aspects of the application. You must ensure that the test cases are traceable to the system requirements and risk assessments. Additionally, you will be required to execute IQ/OQ/PQ to validate the application. It will also be your duty to log, track, and manage defects identified during testing using test management tools. Furthermore, you will need to prepare validation documentation, which includes test scripts, validation protocols, and summary reports. The role requires the ability to work both independently and as part of a team, with a strong emphasis on quality and attention to detail.,

Posted 1 week ago

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