Specialty in injectable lifesaving products including a range of pre and post surgical medications, antibiotics and anti- inflammatory products.
Various Dosage forms like Injectable cartidges, vials and disposable pen device.
- Vacancy details:
- Department : Senior Officer | QA- QMS
- Qualification: M.Pharma
- Experience – 5 – 7 years
- Salary: ₹ 4-5.5 Lacs P.A.
Job Description: Greetings from MJ Biopharm Pvt.Ltd....!!
- Important Details :
- Location: Navi Mumbai
- Post of date:03/06/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Job description
Role & responsibilities
Job Overview:
The Senior Officer – Quality Assurance (QA) – QMS is responsible for ensuring that all aspects of the manufacturing process comply with cGMP, regulatory requirements, and company standards. This role involves overseeing the Quality Management System (QMS) to maintain the highest quality of sterile injectable products.
Key Responsibilities:
- Quality Management System (QMS):
- Develop, implement, and maintain the Quality Management System in compliance with regulatory standards.
- Ensure documentation and records management aligns with cGMP and regulatory requirements.
- Conduct regular internal audits and coordinate external audits to ensure QMS effectiveness.
- Compliance and Regulatory Affairs:
- Ensure compliance with FDA, EU, and other relevant regulatory bodies.
- Prepare and review regulatory submissions and responses to regulatory agencies.
- Stay updated with current regulatory guidelines and industry best practices.
- Quality Assurance Activities:
- Oversee the batch record review process and release of finished products.
- Manage deviations, CAPAs, and change control processes.
- Conduct root cause analysis and risk assessments for quality issues.
- Sterile Manufacturing Oversight:
- Ensure aseptic processing and sterile production operations comply with all regulatory and company standards.
- Monitor environmental control and contamination control procedures.
- Training and Development:
- Develop and deliver training programs related to QMS and GMP compliance for staff.
- Mentor and guide junior QA team members.
- Continuous Improvement:
- Identify areas for quality improvement and implement continuous improvement initiatives.
- Participate in cross-functional teams to drive quality and process improvements.
- Documentation and Reporting:
- Prepare and review QA-related documentation, including SOPs, protocols, and reports.
- Maintain QA metrics and generate regular quality reports for management review.
Qualifications and Skills:
- Education: Bachelor’s/Master’s degree in Pharmacy, Microbiology, Biotechnology, or related field.
- Experience: 5-7 years of experience in QA/QMS within sterile injectable pharmaceutical formulation.
- Knowledge: In-depth knowledge of cGMP, FDA, EU, and other regulatory requirements for sterile injectables.
Preferred candidate profile
Must have experience of sterile Injectable plant .
Interested applicant can send CV on [email protected] or contact on 9619744167
