Senior Officer - Quality Assurance
Mumbai, MaharashtraOn the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Biologics
- Plasma
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
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Job Description
Are you a passionate, dedicated & detailed oriented professional, then the opportunity is for you to join our Quality Assurance Team at Zydus Takeda Healthcare Private Limited, Turbhe, Navi Mumbai - A joint venture of Zydus Lifesciences and Takeda Pharmaceuticals.
For more details logon to -
https://www.takeda.com/en-in/who-we-are/about-zydus-takeda/
Job Title: Senior Officer- Quality Assurance
Location: Navi Mumbai
About the role: The role will be responsible for In-Process Quality Assurance (IPQA) responsible for monitoring and controlling the quality of products during the production process. This role ensures that manufacturing processes comply with regulatory standards and company quality policies to maintain the highest level of product integrity and safety.
How you will contribute:
- Perform real-time monitoring of production processes to ensure adherence to quality standards.
- Conduct routine inspections and in-process checks to verify compliance with specifications and protocols.
- Collaborate with production and quality control teams to address any quality issues promptly.
- Identify deviations - OOS, OOT and non-conformances, and implement corrective and preventive actions (CAPA).
- Ensure proper documentation of all quality-related activities and maintain accurate records. Review Batch Manufacturing Records (BMRs) and Analytical data reviews.
- Review Validations and Qualifications activities & documents.
- Participate in internal audits and inspections to ensure continuous compliance with GMP, SOPs, and other regulatory requirements.
- Provide training and support to production staff on quality procedures and best practices.
- Work closely with the quality assurance team to develop and review quality-related documents, including standard operating procedures (SOPs) and batch records.
Education:
- Master of Science preferable organic chemistry from reputed institute.
- Hands on experience and knowledge of Quality Management System.
- Strong understanding of GMP, FDA regulations, and ICH, cGMP industry standards.
Experience:
- Minimum 3 to 6 years of experience in pharma manufacturing plant preferably API Manufacturing Plant with experience of IPQA in rotational shifts.
- Proficiency in using quality management software and tools like Trackwise.
Desired Skills :
- Excellent observational and attention-to-detail skills.
- Ability to work effectively in a team-oriented, fast-paced environment.
- Strong problem-solving and decision-making capabilities.
- Good documentation and record-keeping skills.
- Continuous improvement mindset and ability to handle multiple tasks efficiently
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
IND - Navi MumbaiWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWorking at Takeda
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Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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