Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

As a Quality Production Specialist, you will play a pivotal role in ensuring flawless production processes. This position is uniquely positioned to influence the implementation of proven quality standards in a collaborative, ambitious environment

The PDS Manufacturing Quality Specialist participate in the day-to-day operations to assure to be complying on the activities in the Manufacturing Department. The focus of the position will be to ensure all documentation is complete and accurate.

Assisting with internal, client and regulatory audits will be encouraged to ensure compliance with cGMP requirements.

A deep understanding of deviation investigations and CAPA will be fundamental for this role.

This person will be responsible for the review/creation cycle of the departmental Procedures, Checklists, Work Instructions, and related Practical Training and will interact in a positive manner on quality-related issues internally and externally.

Supports departmental and cross-functional initiatives for process improvements/enhancements.

Acts as a buddy during onboarding phase and provides training to new staff as needed.

The main responsibilities for this role will be:

Provide documentary support to the production department.Provide for the management of CAPAs, through the Track Wise system, both in terms of opening and closing them on time.Provide for the opening and complete management of the CCF pertaining to the department.Collaborate with the Quality System Department in reviewing the SOP in compliance with GMP, regulatory requirements and corporate guidelines for the establishment.Provide for the execution of training to the department staff and their management through the computer system.To build, review, approve, track and present documents and procedures required for compliance with pharmaceutical regulations.Identify areas of non-compliance, review recommendations of others and implement solutions to resolve major quality and issues. Performs activities across key quality functions to support the manufacturing area.Manage and personally follows internal audits, customer audits, regulatory audits, and all customer visits.Support actions for operational improvements and efficiency improvements with a view to continuous improvement and Operational Excellence.Provide for the training of personnel according to the specific Job Description, monitors and verifies the activities of the personnel mentioned above.Provide support and actively participates in meetings / calls internally and externally.Assist to ensure that downstream manufacturing modules operate efficiently and meet timelines and schedules through according to SOP’s.To apply risk management principlesCollaborate with team members to generate reports on site and corporate performance.

Education, Experience, Knowledge, Skills & Abilities

Diploma with experience (at least 2 years) or Degree in technical-scientific fieldsAbility to work in a fast-paced environment under pressure and be able to multi-task.Italian and EnglishStrong interpersonal and influencing skills – written and verbal.