Posted Mar 04, 2024 230 views
We are seeking a detail-oriented and experienced Quality Control Manager with proficiency in sterility tests, media preparation, LAL tests, endotoxin tests, area monitoring, clean room management, and a specific focus on verifying the sterility of every batch. The ideal candidate will possess industry experience in medical devices, a thorough understanding of quality control processes, and a proven track record in ensuring compliance with regulatory requirements
Regulatory requirements
Please note that due to qualification requirements enforced by Drug Regulatory Authority of Pakistan, notified in Medical Device Rules 2017, we can only consider candidates with the following qualification
- Possess a degree in pharmacy or biomedical engineering or biotechnology from a university or institution recognized by Higher Education Commission and shall possess four years of experience in testing of medical devices or pharmaceuticals
Key Responsibilities:
Microbiological Testing and Sterility Assurance:
- Conduct and oversee sterility tests on products to ensure compliance with regulatory requirements.
- Manage media preparation for microbiological testing, ensuring accuracy and consistency.
- Perform and oversee LAL tests (Limulus Amebocyte Lysate) to detect endotoxins.
Area Monitoring and Clean Room Management:
- Implement and oversee area monitoring procedures to maintain clean and controlled environments.
- Ensure clean rooms fall within established standards for cleanliness and hygiene.
- Conduct regular assessments to verify compliance with clean room standards.
Batch Verification and Release:
- Verify the sterility of every batch before releasing it to the finished goods store.
- Ensure compliance with sterility assurance protocols and regulatory requirements for batch release.
- Perform ongoing stability studies of all finished goods
Quality Control System Management:
- Establish and manage a quality control system specifically tailored to microbiological testing, sterility assurance, area monitoring, and clean room management.
- Develop and maintain documentation related to microbiological testing procedures, including media preparation, LAL tests, endotoxin tests, batch verification, and release procedures.
Regulatory Compliance:
- Ensure compliance with the DRAP Act 2012 and Medical Devices Rules 2017.
- Stay updated on regulatory changes and updates affecting the medical devices industry in Pakistan.
Process Improvement:
- Identify areas for process improvement in microbiological testing procedures, clean room management, batch verification, and release.
- Collaborate with cross-functional teams to implement continuous improvement initiatives in these areas.
Quality Assurance:
- Conduct regular audits and inspections focused on microbiological testing, media preparation, LAL tests, endotoxin tests, area monitoring, clean room management, batch verification, and release.
- Investigate and address any quality-related issues and non-conformances.
Team Leadership:
- Lead, mentor, and developed a team of professionals specializing in microbiological testing, including sterility tests, media preparation, LAL tests, endotoxin tests, area monitoring, clean room management, batch verification, release, and regulatory compliance.
- Provide training and guidance to ensure a high level of competency in these areas.
Qualifications and Experience:
- Bachelor's degree in Pharmacy, Biotechnology, or Biomedical Engineering
- Proven experience as a Quality Control Manager with expertise in sterility tests, media preparation, LAL tests, endotoxin tests, area monitoring, clean room management, batch verification, and release.
- Industry experience in medical devices is preferred.
- In-depth knowledge of the DRAP Act 2012, Medical Devices Rules 2017, microbiological testing standards, sterility assurance protocols, environmental monitoring, clean room standards, and relevant regulations.
- Strong analytical and problem-solving skills.
- Excellent leadership and communication skills.
Job Details
Sehat Medical Devices Pvt Ltd
Sehat Medical Devices Pvt Ltd is a leading manufacturer of high-quality auto-disable syringes and infusion sets dedicated to ensuring the highest standards in healthcare delivery
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