Senior Officer - Quality Assurance

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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.

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