Responsibilities:

1. Management of deviations:

a. Ensures the initiation and investigation of deviations in accordance with the procedures in force in the TW system

b. Is the leader of the local investigation team

c. Ensures that the investigation steps assigned to the specialists in the respective area and the conclusions leading to the identification of the root cause are completed on time.

d. Evaluates the CAPA plan and ensures that it addresses the elimination of the root cause and eventual recurrence of the event

e. Permanently maintains contact with QA specialists and qualified persons (as applicable) so that all steps taken are known and agreed upon in a timely manner

2. Complaints management:

a. Is the leader of the local investigation team

b. It is ensured that the investigative steps assigned to the specialists in the respective area and the conclusions leading to the identification of the root cause are completed on time.

c. Evaluates the CAPA plan and ensures that it addresses the elimination of the cause and eventual recurrence of the event

3. Change control management:

a. Monitors change requests in the TW system

b. Assumes the role of change responsible and coordinates the process of establishing the steps in the change plan, deadlines and change responsibles for the changes initiated by the department

c. Monitors the implementation of the change and ensures that those in charge respect the assumed deadlines and provide evidence of the implementation

4. Manufacturing batch records:

a. Evaluates the new versions of the batch records masters and plays the role of approver together with the area manager

5. Document management:

a. Evaluates the revised versions of local documents (SOP, IL, registers, formats, etc.), ensures that they are in accordance with the requirements of the quality system and the GxP rules, both in terms of format and content

b. Plays the role of reviewer or approver, together with the area manager

c. Manages their distribution and withdrawal in a controlled regime, if/as applicable

d. It ensures compliance with the provisions regarding the archiving of documents with GxP impact

6. Internal/external audit:

a. Performs survey checks in all areas of responsibility and ensures compliance with the procedures and instructions in force, good practices regarding the control of records and aspects related to data integrity

b. Perform internal audits with QA representatives and participate in external audits and authority inspections

c. Part of the compliance gap assessment exercises and remediations plans (generation, execution, follow-up)

d. Escalate to QA and Manager Q the identified risks, risks that could affect compliance, product quality or could bring financial or image damage to the company

7. Performance of the quality system:

a. Collect data, monitor and report to QA the performance indicators of the quality system

b. Follows their evolution and, together with QA and local management representatives, identifies and imposes improvement measures where there are deviations or unfavorable trends

c. Local oversite of the training process (annual plan, training materials review, execution)

d. Follows up on the execution of annual validation, maintenance and calibration activities

e. Review of protocols and reports for facility, equipment, process, product, cleaning qualification and/or validation activities.

Education:

• Graduate in Pharmacy or Chemistry ;
• Experience: 3 -5  years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements
• Knowledge of GMP and regulatory requirements
• Good interpersonal skills and able to manage conflicts
• Skilled in team work
• Investigational skills / techniques
• Must be able to present complicated technical issues in an easy and understandable manner and obtain appropriate actions.
•  PC operating knowledge (MS Office);
•  English: upper intermediate