Quality Assurance System Sr. Manager

3 weeks ago

Jeddah, Saudi Arabia Jamjoom pharma Full time

Jamjoom Pharma has in a very short span of time emerged as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.

**Role Summary**:
Management of Quality systems including, Investigation and CAPA (Corrective Action Preventive Action) System, Management of Risk Assessment System, Manage Product Release and Management of SOPs & documentation.

**Responsibilities**:

- Ensure timely release of the batches.
- Ensure that all documents are reviewed timely and issues in batch document are resolved quickly to release the batch.
- Ensure that issues observed during batch document reviews are escalated at correct level and resolved.
- Ensure that all release data is uploaded timely in regulatory portals.
- To co-ordinate and investigate the events/incidents/deviations identified as necessary for management level action related to CAPA. Prepare and update the CAPA SOP as & when required.
- To initiate CAPA on identified event/incident/deviation and call the CAPA meeting to discuss the event.
- Handling of all the raised CAPA related Product, Processes, Facility, Equipment & Systems during monthly CAPA meeting
- To conduct the detailed investigations (where applicable) as per procedure to determine the root I probable causes of the non-conformities.
- To coordinate with senior management for implementation of actions to avoid re-occurrences of non-compliance.
- Monitoring of implemented CAPA actions for effectiveness.
- To publish a detailed summary of CAPA to implement the actions effectively and timely.
- Responsible for handling of documentation related to CAPA management.
- Tracking of proposed actions and to ensure the actions are implemented within the timeframe.
- Responsible for ensuring compliance of CAPA management SOP.
- To explain management staff any queries regarding CAPA.
- To ensure availability of risk management plan available annually
- Evaluate product quality issues through the risk evaluation process as & when required. Manage product quality issues through quality holds and field action processes and Risk Assessment, where required.
- To co-ordinate with respective department and arrange technical discussion on risk assessment of identified areas.
- To review the risk assessment per formed by the departments as per risk management plan.
- Review of actions identified as part of risk mitigation plan.
- Tracking of risk mitigation and ensuring the actions are implemented.
- Periodic review of risk assessment as per the standard operating procedure.
- Responsible for ensuring compliance of Risk management SOP.
- Responsible for reviewing all SOPs monthly.
- Ensure that the SOP management system is working as per procedure.
- Ensure all document timely archiving and obsoleting.

**Qualifications**:

- Bachelor’s M.Sc. or Doctor of Pharmacy (Pharm B/Pharm D/Science).
- 8 - 10 years of experience in the same role and industry.
- Comprehend SFDA regulations. Well versed with international pharmaceutical standards and pharmacopeia
- Personal Management skill and people management skills
- Audit of third parties and suppliers
- Internal Audit
- Experience and thorough understanding of Quality Assurance functions.
- Knowledge of local and international Guidelines & Regulations.
- Strong communication and computer skills.
- Data analysis and good observation capabilities.
- Target Oriented.
- Quality Agreement.
- Capable of working in stressful conditions.

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