27 Sep
|
Fourrts (India) Laboratories
|
Bengaluru
27 Sep
Fourrts (India) Laboratories
Bengaluru
Company Description Fourrts (India) Laboratories Pvt Ltd is a pharmaceutical company focused on the manufacture and marketing of high-quality dosage forms. The organization is committed to delivering protected, effective, and compliant products that meet regulatory standards and patient needs.
With a growing portfolio and an emphasis on operational excellence, Fourrts (India) Laboratories Pvt Ltd offers opportunities to contribute to robust quality systems and continuous improvement initiatives. Prospective team members can expect a professional environment that values integrity, reliability, and adherence to industry best practices.
Role Description The Senior Quality Assurance Manager is a full-time, on-site role based in Bengaluru. This position is responsible for overseeing the quality assurance function, including the implementation, monitoring, and continuous improvement of quality systems for dosage form manufacturing.
Day-to-day activities include reviewing and approving batch records, SOPs, and validation documents; managing deviations, CAPA, and change controls; and ensuring compliance with GMP and regulatory requirements. The role also involves leading QA audits and inspections, coordinating with cross-functional teams such as production, QC, and regulatory affairs, and mentoring QA staff to maintain consistent quality standards.
The Senior Quality Assurance
Manager will support risk management, root cause analysis, and documentation practices to sustain a culture of quality and compliance.
Qualifications
- Strong background in pharmaceutical quality assurance and GMP compliance, with experience in dosage form manufacturing.
- Proficiency in quality systems management, including deviations, CAPA, change control, and documentation control.
- Experience with internal and external audits, regulatory inspections, and preparation of related reports and responses.
- Ability to lead and develop QA teams, with skills in coaching, performance management, and cross-functional collaboration.
- Sound knowledge of validation principles, including process validation, equipment qualification, and cleaning validation.
- Excellent analytical, problem-solving, and root cause analysis skills, with attention to detail and accuracy.
- Strong written and verbal communication skills for preparing quality documentation, reports, and training materials.
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or a related scientific discipline.
- Several years of progressive experience in pharmaceutical QA, including leadership responsibilities.
- Familiarity with Indian and international regulatory guidelines (e.g., CDSCO, WHO, FDA, EMA) is an advantage.
📌 Senior Quality Assurance Manager (Bengaluru)
🏢 Fourrts (India) Laboratories
📍 Bengaluru