Executive / Senior Executive - Injectable Manufacturing Quality Management System
Bavla, Gujarat, India · Full Time
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- Experience
- 5–12 yrs
- Salary
- —
- Openings
- 1
- Posted
- há 1 hora
- Work mode
- In office
- Education
- B.Pharm
- Eligibility
- Candidates holding a Bachelor of Pharmacy degree in any specialization are eligible to apply.
- Resume
- Required to apply
Where you'll work
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Job description
About INTAS Foundation
INTAS Foundation, as the corporate social responsibility division of INTAS Pharmaceuticals Ltd., is dedicated to uplifting marginalized communities through initiatives like Apna Ghar, Blood Bank support, Patient Assistance Programs, and various community projects. Their outreach has positively impacted over 2 million lives across 25 states and union territories in India by delivering meaningful developmental programs.
Role and Responsibilities
In this position, you will be responsible for comprehensive management of quality systems within the injectable manufacturing environment, encompassing documentation, compliance, quality assurance, and sterile process integrity.
- Investigate production deviations by creating detailed, scientifically-based reports capturing root causes and implications.
- Apply root cause analysis techniques such as Fishbone diagrams and the 5 Whys method to identify issues and develop corrective and preventive actions (CAPA).
- Manage change controls effectively by initiating, reviewing, and monitoring changes related to equipment, processes, and documentation.
- Assist with investigating environmental monitoring deviations including Out of Specification (OOS) and Out of Trend (OOT) results.
- Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) to ensure compliance ahead of Quality Assurance submission.
- Maintain strict adherence to current Good Manufacturing Practices (cGMP) within the injectable manufacturing area.
- Review electronic audit trails for manufacturing equipment and compounding systems to verify data integrity.
- Support regulatory audit preparedness and responses, including USFDA and MHRA inspections.
- Maintain and review online logbooks, validation protocols, and area qualification reports.
- Develop and implement Media Fill protocols, carrying out process simulation validations for sterile manufacturing.
- Conduct Quality Risk Management (QRM) assessments focused on sterile compounding and filling processes.
- Write and update Standard Operating Procedures (SOPs) relating to manufacturing operations.
Candidate Profile and Qualifications
- Professional experience ranging from 5 to 12 years in pharmaceutical manufacturing environments.
- Educational background requiring a Bachelor’s or Master’s degree in Pharmacy (B.Pharm or M.Pharm).
Minimum education
Bachelor's Degree
Industry
Pharmaceuticals