Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

Post : Senior Executive / Executive – Quality Assurance

Job Description

• 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.

Candidate Profile
• 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.

• 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.
• 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

Additional Information
Experience : 6 to 8 years
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QA
End Date : 30th May 2025

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