Senior Officer

2 weeks ago

Mumbai, Maharashtra, India Takeda Full time ₹ 6,00,000 - ₹ 18,00,000 per year

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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 Company Details logon to -

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:

  • Post Graduate / Graduate in Science or Pharmacy 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 6 to 8 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, SAP, etc.

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
LocationsIND - Navi MumbaiWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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