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Company Description CAREWELL STEUART PHARMA PRIVATE LIMITED is a pharmaceutical company headquartered in Chennai, Tamil Nadu, India. The organization focuses on providing quality pharmaceutical products and services to support healthcare needs across the region. Team members work in a regulated environment that emphasizes product safety, compliance, and continuous improvement. The company offers opportunities for growth for individuals interested in contributing to high standards in pharmaceutical manufacturing and quality assurance.
Role Description The Senior Executive Quality Assurance role is a full-time, on-site position based in Tiruvallur. This role involves overseeing day-to-day quality assurance activities, including review and approval of quality documentation, standard operating procedures, batch manufacturing records, and validation protocols. The Senior Executive will monitor compliance with regulatory and company standards, coordinate internal audits, support external inspections, and ensure timely investigation and closure of deviations, change controls, and CAPAs. Responsibilities include collaborating with production, QC, and regulatory teams to maintain GMP standards, supporting training on quality systems, and driving continuous improvement initiatives in quality processes. The role also requires maintaining accurate records, preparing reports and metrics for management, and contributing to risk assessments and quality-related decision-making.
Qualifications
- Candidates should possess strong knowledge of pharmaceutical quality assurance principles, including GMP, GLP, and relevant regulatory guidelines.
- Candidates should possess skills in documentation management, including drafting, reviewing, and approving SOPs, batch records, and validation or qualification reports.
- Candidates should possess experience in quality systems such as deviation management, change control, CAPA, internal audits, and risk assessment.
- Candidates should possess abilities in cross-functional collaboration with production, QC, warehousing, and regulatory teams to maintain compliance and resolve quality issues.
- Candidates should possess strong analytical, problem-solving, and decision-making skills, with attention to detail and accuracy.
- Candidates should possess effective written and verbal communication skills, and the ability to prepare clear reports and present quality findings.
- Candidates should possess a bachelor’s degree or higher in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline, and prior experience in pharmaceutical QA (senior or supervisory level preferred).
- Candidates should possess the ability to work on-site in Tiruvallur, manage multiple priorities, and contribute to training and mentoring of junior team members.
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