Experience
- At least 3 years
- The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
Education
B.Pharm/M.Pharm from a reputed university with a sound academic record.
Requirements
- At least 3 years
- The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
Additional Requirements
- Age At most 35 years
3 to 10 years of relevant experience in the sterile manufacturing area of a pharmaceutical company.
Candidates without relevant sterile manufacturing experience will not be considered.
Strong analytical, communication, coordination, and documentation skills.
Computer proficiency, including MS Office applications and professional email communication.
Responsibilities & Context
Implement and maintain the pharmaceutical Quality Management System in accordance with cGMP and applicable regulatory requirements.
Monitor GMP compliance across sterile manufacturing, aseptic processing, filling, packaging, and supporting operations.
Review batch manufacturing and packaging records and coordinate batch disposition in accordance with approved procedures and authorization.
Prepare, review, and update SOPs, quality documents, and related technical procedures.
Coordinate deviation investigations, CAPA, change control, risk assessments, and other QMS activities.
Oversee applicable validation and qualification activities, including process validation, cleaning validation, sterilization validation, and aseptic process simulation.
Monitor environmental control, contamination control practices, and compliance with cleanroom requirements in coordination with relevant departments.
Conduct internal audits, support regulatory inspections, and follow up on identified compliance gaps.
Review quality trends and documentation to support continuous improvement.
Experience in preparing and regularly maintaining APQR for all products
Coordinate GMP training and promote quality awareness among employees.
Job Location: Factory- BSCIC Industrial Area, Jhumjhumpur, Jashore
Job Other Benifits
Provident Fund, Gratuity, Festival Bonuses Health service benefits as per company policy