Open Vacancies At Nerhadou International
1-Production Pharmacist
Job purpose
- Follow up on all the activities done in the production area
- Ensure the Implementation of all GMP Guidelines in the department
- Track the performance of operators in the department
Responsibilities and tasks
- Follow up all the activities done in the production area
- Ensure that all materials used comply with BPRs & orders.
- Make sure that all BPRs procedures for products are implemented in the department.
- Ensure that all steps of operations in the department are done as required.
- Support everyone in the department to be well-trained and qualified for the assigned job.
- Ensure the implementation of all SOPs in the department.
- Overcome all troubleshooting appearing in the department.
- Make reconciliation of batches and state any comments if there are any out of reconciliation limit appears.
Job Specifications
Education: B.SC of Pharmacy
Experience: (0-3) years of experience in similar preferably in the pharmaceutical field
2-Quality Control Finished Products Sr. Analyst
1- JOB PURPOSE:
Develop, implement, and maintain the bulk and finished product sample analysis, according to specification & method of analysis and in compliance with regulatory requirements.
Monitor analytical activities during quality studies like process validation, cleaning validation and hold time studies.
2- DIMENSIONS:
Physical and chemical analysis of bulk and finished product samples.
Review and check the analysis results. Reporting the data using statistical tools with interpretation of the results.
Monitor and check analysis work related to quality assurance studies.
Prepare and review the relevant quality control documents.
3- RESPONSIBILITIES AND TASKS:
Perform physical testing and chemical analysis of different pharmaceutical dosage forms.
Prepare and standardizes volumetric solutions, reagents, dissolution media and buffers.
Follows the controlled standard operating procedures and work instructions of finished product specifications and test methods during analysis process.
Maintain the quality control approved control records related to the daily work.
Issues and signs test certificates.
Report and participate in the investigation of any OOS case or NCR.
Review, Check & follow up on all results of bulk, semi-finished & finished products.
Prepare and write the relevant quality control documents as specifications, analytical monographs, sampling processes and technical instructions.
Training the analysts & Subordinates.
Implementation of good documentation practices ( GDP ) and good laboratory practices (GLP) in Qc labs.
Follow up and review subordinates.
Handling & control of lab equipment during lab activities.
Calibration of all analytical instruments in the Quality Control Lab.
Recording the activities in the operation and instrument logbooks
Be aware and follow safety measures in the lab.
Participating in APR analysis by trending QC data.
4- JOB SPECIFICATIONS:
Education :
o Bachelor of Science, or pharmacy.
Experience:
3 – 5 years
3-Quality Assurance Sr. Compliance Officer
JOB PURPOSE:
· This position is responsible for assisting with Quality Assurance tasks and managing company documents while also ensuring their accuracy, quality, and integrity. Adheres to record retention policies, safeguards information, and retrieves data more effectively.
· Initiate, Review, and approve deviations, CAPAs, and change controls.
DIMENSIONS
· Issue and follow up CAPA, Deviation, incident, and change control documents.
· Annual product review (APR) data collection and analysis.
· Preparation of Common Technical Documents (CTD) files for Pharmaceutical and Nutraceuticals products.
· Participate in internal audit program and vendor qualification audits.
· Stoppage of any process where Quality measurements or GMP is not conducted.
RESPONSIBILITIES AND TASKS:
· Preparation of CTD files according to ICH guidelines.
· Expertise proficiency with software tools and matrices for CTD submission.
· Provide regulatory reviews of customer complaints and define the regulatory responsibility.
· Conducting internal audits for the production department, engineering, warehouse, etc.
· Perform the intermediate and finished product and on-line inspections.
· Regular check of RH (%), DP, and temperature in different production areas.
· Reporting any deviation that happened in the production area.
· Handling of returned drug products.
· Responsible for Annual product review data collection.
· Coordinate / Support Change Controls as needed.
· Write, review, and approve Policies, Standard Operating Procedures (SOPs), and associated processes/guidelines.
· Coordinate activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish notes and action items from meetings; provide support to the investigation process and follow-up to assure timely discrepancy closure.
· Perform independent quality evaluation of deviation reports including root cause analysis cause/preventive action identification, CAPA effectiveness check, and trending.
· Ensure that inspection and audit responses are completed from initiation to closure.
· Support activities to evaluate regulatory compliance.
· SOP writing/revision
· Participate in the internal audit program, vendor qualification audits,
· Initiate, Review, and approve deviations, CAPAs, and change controls.
· Revise and issue the SOPs for all the departments.
· Check in-process testing done by production technicians by performing testing, reviewing test data, and writing investigations according to SOPs and GMPs.
JOB SPECIFICATIONS:
· Education: Bachelor of pharmacy or science.
· Experience:
o (3-5) years of experience.
o Experience in the preparation of Common Technical Documents (CTD) files for Pharmaceutical and Nutraceuticals products
4-Supply Chain Officer
1- JOB PURPOSE:
Implement optimization process for the supply chain and planning department.
2- RESPONSIBILITIES AND TASKS:
Participate in the development of the supply chain strategy for the organization.
Coordinate the process of supply/demand forecasting, inventory utilization, and on time delivery.
Support the continuous quality improvement of the APIs and excipients required for production.
Planning delivery timetables.
Ensuring stores have enough stock.
Making sure suppliers have enough stock to meet the demand.
Overseeing the ordering and packaging process.
Monitoring stock levels.
Tracking products through depots to make sure they arrive at their destination.
3- JOB SPECIFICATIONS:
Education:
Bachelor’s degree in pharmaceutical science
Experience:
1-3 years supply chain in a pharmaceutical company
Interested applicants should send their CV to Job@nerhadou.com and mention the position subject line.