Job Title:
Senior Officer - Quality Assurance
Company:
Zydus Takeda Healthcare Private Limited (A Joint Venture of Zydus Lifesciences and Takeda Pharmaceuticals)
Job Location:
Navi Mumbai, Maharashtra, India
Job Type:
Full-Time
Role Overview:
The Senior Officer - Quality Assurance will be responsible for monitoring and controlling the quality of products during the production process. The role ensures that manufacturing processes comply with regulatory standards and company quality policies to maintain product integrity and safety.
Roles & Responsibilities:
In-Process Quality Assurance (IPQA):
Perform real-time monitoring of production processes to ensure compliance with 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.
Identify deviations, Out of Specifications (OOS), Out of Trend (OOT) and non-conformances; implement corrective and preventive actions (CAPA).
Maintain proper documentation of all quality-related activities and review Batch Manufacturing Records (BMRs) and Analytical data.
Review validation and qualification activities and documents.
Training & Development:
Provide training and support to production staff on quality procedures and best practices.
Compliance:
Participate in internal audits and inspections to ensure continuous compliance with GMP, SOPs, and regulatory requirements.
Work closely with the quality assurance team to develop and review quality-related documents such as SOPs and batch records.
Qualifications:
Education:
Master of Science (preferably in organic chemistry) from a reputed institute.
Experience:
Minimum 3 to 6 years of experience in a pharma manufacturing plant, preferably API Manufacturing Plant.
Hands-on experience with Quality Management Systems (QMS).
Experience in IPQA with rotational shift work.
Skills & Expertise:
Strong understanding of GMP, FDA regulations, ICH, and cGMP industry standards.
Proficiency in using quality management software and tools like Trackwise.
Excellent observational and attention-to-detail skills.
Ability to work effectively in a fast-paced, team-oriented environment.
Strong problem-solving and decision-making capabilities.
Good documentation and record-keeping skills.
Continuous improvement mindset.
About Takeda:
Takeda is transforming patient care through the development of novel specialty pharmaceuticals. The company is committed to fostering an inclusive, collaborative workplace with an unwavering commitment to delivering better health and a brighter future to people around the world.
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