Duties and Responsibilities:
a. Review production and quality control batch records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
b. Approve specifications of raw materials, packaging materials, bulk products, and finished products.
c. Approve and authorize all documents included in the quality management system, including amendments.
d. Ensure proper design, effective implementation, monitoring and maintenance of the quality management system.
e. Retain records in accordance with approved procedures, GMP, ISO 9001:2015 and regulatory requirements.
f. Ensure investigation of deviations, change control, non-conforming products, out of specifications, customer complaints and products recalls.
2. Team development:
a. Ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
b. Conduct employee performance tracking and evaluation by applying the employee performance management procedure.
3. Quality Assurance activities:
a. Ensure all operations are carried out in accordance with written procedures and, where necessary, recorded.
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.
c. Approve and authorize the manufacturing formula.
d. Approve and monitor outsourced contract manufacturing and analysis activities.
e. Establish and maintain the company quality assurance system according to ISO9001:2015 and the good manufacturing practices requirements.
f. Ensure that company risks are assessed and managed to increase the effectiveness of the QMS, achieve improved results and prevent negative effects.
g. To approve or reject, as he/she sees fit, starting materials, packaging materials, intermediate, bulk and finished products.
h. Approve the suppliers of starting and packaging material.
i. Review and approve the stability report of the products and designate appropriate storage condition and expiry dates based on stability result.
j. Maintain an inventory of documents within the Quality Management System.
k. Ensure the accurate management of complaint, deviation, out of specification, change control, recall, NCP and quality defect investigations by experienced and well trained personnel, and approve the measures taken to manage any potential risk(s) presented by those issues.
l. Ensure that all returned product due to quality defect is regarded and managed as a recall.
m. Monitor and approve the identified CAPAs taken in response to a quality defect or any other possible source.
n. Ensure the appropriate documentation of relative role and responsibilities of the concerned parties in case the complaint and quality defect handling is managed centrally within the organization.
o. Ensure that all line clearance and quality inspections are done.
p. Conduct product annual review.
4. Inspection and monitoring:
a. Monitor and ensure compliance with the requirements of GMP and ISO 9001:2015.
b. Conduct self-inspection in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.
a. Report on the performance and opportunities for improvement of quality assurance process by monitoring achievement of its quality objectives and performance indicators.
b. Conduct management reviews of process performance, product quality and of the quality management system and advocating continual improvement.
c. Set internal quality audit plan and ensure its implementation.
d. Perform internal audit on designated departments based on internal audit plan and according to internal auditor job description.
a. Assure attainment of business objectives and quality assurance schedules while insuring product required quality.
b. Set the human and material resources needed and optimize resource utilization for the effective implementation of the production planning.
c. Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
d. Develop quality assurance plans by conducting hazard analyses, identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, corrective actions and verification procedures.
e. Work closely with technical team (QC and Production) on new investments, researches and documents preparation for products’ registration in potential countries.
f. Manages the QA and QC Divisions.
a. Accept and work any task related to quality assurance activity required by top management.
|Job Location:||Beirut, Lebanon|
|Job Role:||Quality Control|
|Company Industry:||Pharmaceutical; Manufacturing and Production; Medical/Hospital|
Source: Bayt.com Jobs
To apply for this job please visit the following URL: https://www.bayt.com/en/lebanon/jobs/quality-manager-3755029/ →