Officer - QA (Fixed Term Contract) - API Manufacturing

Education Qualification:

MSc. (Analytical/ Organic) from reputed institute / university

Experience: 1 to 5 Yrs in API Manufacturing Plant with experience of IPQA in rotational shifts.

Role & responsibilities

• 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.

Technical Skills:

• Proficiency in using quality management software and tools like Trackwise.
• Strong understanding of GMP, FDA regulations, and ICH, cGMP industry standards.
• Hands on experience and knowledge of Quality Management System.

Competencies/Behaviours :

• 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