Senior Vice President Quality Control
About Yashraj Biotechnology Ltd.
We are a research and innovation driven, UL registered and ISO 13485:2016, ISO 9001:2015 and OHSAS 18001:2007 certified company, established during 1999 in Navi Mumbai, Maharashtra, India. We have operations in Germany, USA and soon in South Korea. Our research, development and production-related activities encompass a whole range of native, recombinant and cell-derived antigens; and monoclonal antibodies. Highest standards of quality and unwavering commitment towards healthcare innovation has enabled us to capture some of the biggest market segments for various biomarker antigens and antibodies it develops.
We encourage and facilitate the creation, discovery, dissemination and application of new knowledge and foster academic alliances. We have entered in the area of induced pluripotent stem cell-derived disease specific models for high-throughput drug screening and toxicology testing. A bio-repository of human clinical specimens from patients with broad clinical categories of cancer has been established to isolate their cellular derivatives (primary cancer cells, blood-derived iPSCs, iPSC-derived differentiated cardiomyocytes and hepatocytes). Through this program we plan to contribute to new drug discovery; personalized medicine for patients; and stem cell and tissue banking.
In addition, we have initiated R&D for production of recombinant antibodies using Phage Display Technology.
Research and Development (R&D) work at YBL is approved by the Department of Science and Industrial Research, Ministry of Science and Technology, Government of India.
To diversify and grow further, we are considering merger and acquisition of companies in the similar or related line of business. Through projected growth in current business and expansion and diversification, YBL plans to reach yearly turnover of USD 60 Mn in the next five years with Net Profit of USD 20 Mn.
Currently we have over 60 qualified scientists, about 40 administrative and marketing personnel supported by 100 Blue collared work force (total work force of 200 people) actively undertaking research projects befitting the vision and mission of the company and production-related work.
Capability to promote Quality and Compliance, able to motivate sites and units to continuous levels of quality excellence and regulatory awareness
Should have handled Quality Control function independently
In-depth Knowledge of QC processes, ISO 13485:2016, ISO 9001:2015 standards in Biotech industry
Strong domain knowledge of biotechnology, biochemistry or life sciences or pharmaceutical.
Knowledge and skills required to achieve the overall purpose of the job, gained through education, training and experience (in house and external).
Regulatory knowledge and understanding to achieve the overall purpose of the job gained through training and experience both internal and external.
Take ownership of decision taken, problem solver and analytical mind set.
Required awareness of assessment context (national and international customers and regulators).
Very good communicator and good listener.
Eye for details and identify problem with solution-oriented approach.
Expert in particular field in which organization deal with good communication skill (written and oral).
Work largely on self-initiative and effectively evaluate the most complex assessment.
Coordination skills to manage multiple stakeholders.
Creative thinker and Tech savvy.
Should have a degree in pharmacy or other relevant scientific discipline.
Candidate with minimum 10 years of experience.
We are gender neutral.
Oversee the Quality Control operations and services and ensure compliance to Current Good Manufacturing Practices (cGMP)/ USFDA and other regulatory requirements.
Conduct product and process quality checks following established work instructions and sampling plans, and ensure that all products and processes meet the standards, Customer quality requirements, and regulatory requirements and regulatory requisites.
Should work as informed voice of customers in our premises.
On time planning and reviewing of verification & validation of new products as per specifications submitted by R&D.
On time SOP revision, MQR revision, and QC documentation as per the SOP.
Should have up to date knowledge of a broad range of scientific activities in addition to specialist knowledge in one or more relevant scientific areas. Is recognized both within the organization and within peers as an expert or opinion leader.
Demonstrates a detailed working knowledge and experience of all relevant regulations in one or more areas of regulatory activity within the organization.
Should provide input into the development of key regulatory systems policies or definitive guidelines as a recognized expert (both within and outside the organization).
Provides authoritative leadership in dealing with the most difficult technical or regulatory issues and makes them accessible to others.
Acts as a peer reviewer / mentor for the work of others.
Participates autonomously in international assessment context. Represents home organization at international level.
Assesses (and/or supports the assessment of) range of the most sensitive or complex issues. Coaches others, advises colleagues in own area of specialization and provides technical support where required. May act as a mentor to colleagues.
Writes and critically evaluates written assessment reports and presentations.
Influential in international networks, collects and critically evaluates new and evolving information and influences standards and opinions.
Should represent the Agency on scientific / Regulatory policy issues.
Give direction to team and lead from front.
Always give due regards to Vision & Mission, ethics and culture of our company.
Create leadership who can face any situation or challenge with healthy competition and environment where all follow “We do what we say, we say what we do”.
Create conducive environment for personnel and professional growth of each and every team member with succession plan and desired skill matrix required for the same.
Accountable to President Operations
Some travel may be required to carry out duties and responsibilities.
At times may have to travel to conferences/workshops for new skill development.
Compensation and other perquisites would not be a constraint for the right candidate and family accommodation will be provided by the Organization.
For more information about Yashraj Biotechnology Ltd. please visit www.Yashraj.com
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