Serum Products jobs
4 Jobs Found
Serum Products
Lebanon - Beirut
<p><strong>GMP Compliance:</strong></p><ul><li><strong>Documentation:</strong><ul><li>Retain records in accordance with approved procedures, GMP, ISO 9001:2015, ISO 13485:2016, ISO 15378:2017.</li><li>Write processes and procedures related to regulatory affairs department.</li><li>Archive all regulatory documentation including submissions and approvals in accordance with policies.</li><li>Update the registration list and status for all products.</li></ul></li><li><strong>Regulatory Affairs activities:</strong><ul><li>Carry out all actions in accordance with written procedures and, where necessary, recorded.</li><li>Comply with the global strategy and objectives of the general management and organization.</li><li>Ensure that SP products comply with the Registration regulations of Lebanon.</li><li>Develop registration applications (Pharmaceutical and Pharmaceutical-Like) to be submitted locally and internationally.</li><li>Submit new registration applications and follow up on the appropriate licensing and regulatory compliance of pharmaceutical and/or medical products.</li><li>Collaborate with concerned internal departments to continuously develop the portfolio to meet local needs and ensure profit and growth to the company.</li><li>Develop professional relationships with governmental staff.</li><li>Apply for trademark s registration at the Ministry of Economy & Trade.</li><li>Ensure that all regulatory aspects of the applications at the Ministries level and other Governmental institutions are met within the requested time frame.</li><li>Attend authorities inspection of plant and premises.</li><li>Ensure timely Marketing Authorization Approval of the products submitted for registration.</li><li>Submit variations and pricing applications to the Ministry of Public Health and make the necessary follow-up till final approval.</li><li>Apply for the introduction of products in Hospitals and other institutions and make the necessary follow up till approval.</li><li>Apply for the expansion of the manufacturing site and any related division and follow up till approval and permit issuance</li><li>Apply for the certification and renewal of certification of the manufacturing site and follow up till approval and certificate issuance</li><li>Ensure compliance of the New Submission dossiers towards Export registration guidelines, and ensure proper dispatch to the concerned distributors in all countries, including communication to receiver and preparation of samples.</li><li>Actively follow up on registration development / applications status (through distributors and directly) till review of the applications and their final approval.</li></ul></li><li><strong>Inter-departmental tasks:</strong><ul><li>Procurement: Assist in the clearance of goods through the control of shipping documents prior to their submission to Ministry of Public Health (MOPH) and through due follow up with the MOH when needed.</li></ul></li><li><strong>ISO Compliance:</strong><ul><li>Report on the performance and opportunities for improvement of regulatory affairs process by monitoring achievement of its quality objectives and performance indicators.</li><li>Participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.</li></ul></li><li><strong>Management:</strong><ul><li>Assure attainment of business objectives.</li><li>Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.</li><li>Work closely with technical team (QC, QA& Production) on new investments, researches and documents preparation for products registration in potential countries.</li></ul></li><li><strong>Others:</strong><ul><li>Accept and work any task related to regulatory affairs activity required by the Operations and Technical Manager.</li></ul></li></ul><p><strong>Desired Candidate Profile</strong></p><p>Fresh Graduate.</p>
Serum Products
Lebanon - Beirut
<p>Fresh Graduate</p><p><strong>Duties and Responsibilities:</strong></p><p><strong>GMP Compliance:</strong></p><p>1. Documentation:</p><ul><li>a. Follow up on production records and manufacturing batch records to ensure they are filled adequately as per good documentation practices, that no errors have occurred or, if errors have occurred, that they have been fully investigated, and make sure they are signed by the authorized person.</li><li>b. Retain records in accordance with approved procedures, GMP, ISO 9001:2015, ISO 13485:2016 and ISO 15378:2017 and regulatory requirements.</li><li>c. Report immediately and participate in any deviation, out of specification, non-conforming product, maintenance request and change control request.</li><li>d. Write and update procedures and all documents related to production department.</li><li>e. Ensure the implementation of procedures and instructions related to production operations.</li></ul><p>2. Team development:</p><ul><li>a. Perform the required initial and continuing training of his department personnel according to need.</li><li>b. Conduct employee performance tracking and evaluation by applying the employee performance management procedure.</li></ul><p>3. Production activities:</p><ul><li>a. Ensure all operations are carried out in accordance with written procedures and, where necessary, recorded.</li><li>b. Ensure that plant hygiene procedures are understood and followed in a very strict way by every person whose duties take him into the production and control areas.</li><li>c. Supervise the whole production operation to ensure that pharmaceuticals products are manufactured and stored according to the set requirements in order to obtain the required quality.</li><li>d. Supervise repacking activities and check needed reports.</li><li>e. Ensure online monitoring and control of production activities.</li><li>f. Ensure that the correct materials are accurately weighed or measured into clean and properly labelled containers.</li><li>g. Check the integrity of the sterilized filter before use and confirm it immediately after use by an appropriate method such as a bubble point, diffusive flow or pressure hold test.</li><li>h. Issue and authorize printed packaging materials for use following an approved and documented procedure.</li><li>i. Supervise the inspection, investigation and taking of samples related to product quality.</li></ul><p>4. Inspection and monitoring:</p><ul><li>a. Monitor and ensure compliance with the requirements of GMP and ISO 9001:2015, ISO 13485:2016 and ISO 15378:2017.</li><li>b. Conduct self-inspection in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.</li></ul><p>5. Premises and equipment:</p><ul><li>a. Coordinate with maintenance team to avoid interruptions in production schedule.</li><li>b. Ensure the calibration, qualification and maintenance of his/her department, premises and equipment.</li><li>c. Ensure all premises are clean before any processing or packaging activities begin and are free from any products, materials or documents previously used if these are not required for the current operation.</li><li>d. Ensure that manufacturing equipment are cleaned according to detailed and written procedures and stored in adequate.</li><li>e. Oversee the logbooks of machine to ensure all activities are recorded on logbooks of respective machines.</li></ul><p><strong>ISO Compliance:</strong></p><ul><li>a. Participate in reporting on the performance and opportunities for improvement of production process by monitoring achievement of its quality objectives and performance indicators.</li><li>b. Participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.</li></ul><p><strong>Management:</strong></p><ul><li>a. Assure attainment of productions schedules while ensuring product required quality.</li><li>b. Adjust resource utilization for the effective implementation of the production planning.</li><li>c. Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.</li></ul><p><strong>Others:</strong></p><ul><li>a. Accept and work any task related to production activity required by Production Manager.</li></ul><p><strong>Desired Candidate Profile</strong></p><p>Fresh Graduate</p>
Serum Products
Lebanon - Beirut
Fresh Graduate
<br>Duties and Responsibilities:
<br> GMP Compliance:
<br>1. Documentation:
<br>a. Follow up on production records and manufacturing batch records to ensure they are filled adequately as per good documentation practices, that no errors have occurred or, if errors have occurred, that they have been fully investigated, and make sure they are signed by the authorized person.
<br>b. Retain records in accordance with approved procedures, GMP, ISO 9001:2015, ISO 13485:2016 and ISO 15378:2017 and regulatory requirements.
<br>c. Report immediately and participate in any deviation, out of specification, non-conforming product, maintenance request and change control request.
<br>d. Write and update procedures and all documents related to production department.
<br>e. Ensure the implementation of procedures and instructions related to production operations.
<br>
<br>2. Team development:
<br>a. Perform the required initial and continuing training of his department personnel according to need.
<br>b. Conduct employee performance tracking and evaluation by applying the employee performance management procedure.
<br>3. Production activities:
<br>a. Ensure all operations are carried out in accordance with written procedures and, where necessary, recorded.
<br>b. Ensure that plant hygiene procedures are understood and followed in a very strict way by every person whose duties take him into the production and control areas.
<br>c. Supervise the whole production operation to ensure that pharmaceuticals products are manufactured and stored according to the set requirements in order to obtain the required quality.
<br>d. Supervise repacking activities and check needed reports.
<br>e. Ensure online monitoring and control of production activities.
<br>f. Ensure that the correct materials are accurately weighed or measured into clean and properly labelled containers.
<br>g. Check the integrity of the sterilized filter before use and confirm it immediately after use by an appropriate method such as a bubble point, diffusive flow or pressure hold test.
<br>h. Issue and authorize printed packaging materials for use following an approved and documented procedure.
<br>i. Supervise the inspection, investigation and taking of samples related to product quality.
<br>
<br>4. Inspection and monitoring:
<br>a. Monitor and ensure compliance with the requirements of GMP and ISO 9001:2015, ISO 13485:2016 and ISO 15378:2017.
<br>b. Conduct self-inspection in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.
<br>
<br>5. Premises and equipment:
<br>a. Coordinate with maintenance team to avoid interruptions in production schedule.
<br>b. Ensure the calibration, qualification and maintenance of his/her department, premises and equipment.
<br>c. Ensure all premises are clean before any processing or packaging activities begin and are free from any products, materials or documents previously used if these are not required for the current operation.
<br>d. Ensure that manufacturing equipment are cleaned according to detailed and written procedures and stored in adequate.
<br>e. Oversee the logbooks of machine to ensure all activities are recorded on logbooks of respective machines.
<br>
<br> ISO Compliance:
<br>a. Participate in reporting on the performance and opportunities for improvement of production process by monitoring achievement of its quality objectives and performance indicators.
<br>b. Participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.
<br> Management:
<br>a. Assure attainment of productions schedules while ensuring product required quality.
<br>b. Adjust resource utilization for the effective implementation of the production planning.
<br>c. Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
<br>
<br> Others:
<br>a. Accept and work any task related to production activity required by Production Manager
Serum Products
Lebanon - Beirut
Fresh Graduate.
<br>Duties and Responsibilities:
<br> GMP Compliance:
<br>1. Documentation:
<br>• Retain records in accordance with approved procedures, GMP, ISO 9001:2015, ISO 13485:2016, ISO 15378:2017.
<br>• Write processes and procedures related to regulatory affairs department.
<br>• Archive all regulatory documentation including submissions and approvals in accordance with policies.
<br>• Update the registration list and status for all products.
<br>
<br>2. Regulatory Affairs activities:
<br>• Carry out all actions in accordance with written procedures and, where necessary, recorded.
<br>• Comply with the global strategy and objectives of the general management and organization.
<br>• Ensure that SP products comply with the Registration regulations of Lebanon.
<br>• Develop registration applications (Pharmaceutical and Pharmaceutical-Like) to be submitted locally and internationally.
<br>• Submit new registration applications and follow up on the appropriate licensing and regulatory compliance of pharmaceutical and/or medical products.
<br>• Collaborate with concerned internal departments to continuously develop the portfolio to meet local needs and ensure profit and growth to the company.
<br>• Develop professional relationships with governmental staff.
<br>• Apply for trademark’s registration at the Ministry of Economy & Trade.
<br>• Ensure that all regulatory aspects of the applications at the Ministries level and other Governmental institutions are met within the requested time frame.
<br>• Attend authorities’ inspection of plant and premises.
<br>• Ensure timely Marketing Authorization Approval of the products submitted for registration.
<br>• Submit variations and pricing applications to the Ministry of Public Health and make the necessary follow-up till final approval.
<br>• Apply for the introduction of products in Hospitals and other institutions and make the necessary follow up till approval.
<br>• Apply for the expansion of the manufacturing site and any related division and follow up till approval and permit issuance
<br>• Apply for the certification and renewal of certification of the manufacturing site and follow up till approval and certificate issuance
<br>• Ensure compliance of the New Submission dossiers towards Export registration guidelines, and ensure proper dispatch to the concerned distributors in all countries, including communication to receiver and preparation of samples.
<br>• Actively follow up on registration development / applications status (through distributors and directly) till review of the applications and their final approval.
<br> 3. Inter-departmental tasks:
<br>• Procurement: Assist in the clearance of goods through the control of shipping documents prior to their submission to Ministry of Public Health (MOPH) and through due follow up with the MOH when needed.
<br> ISO Compliance:
<br>• Report on the performance and opportunities for improvement of regulatory affairs process by monitoring achievement of its quality objectives and performance indicators.
<br>• Participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.
<br> Management:
<br>• Assure attainment of business objectives.
<br>• Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
<br>• Work closely with technical team (QC, QA& Production) on new investments, researches and documents preparation for products’ registration in potential countries.
<br> Others:
<br> Accept and work any task related to regulatory affairs activity required by the Operations and Technical Manager