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 participates in the day-to-day operations to assure compliance with 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 and creation cycle of departmental Procedures, Checklists, Work Instructions, and related Practical Training and will interact positively on quality-related issues internally and externally.
Supports departmental and cross-functional initiatives for process improvements/enhancements.
Acts as a buddy during the onboarding phase and provides training to new staff as needed.
Main Responsibilities Provide documentary support to the production department.Manage CAPAs through the Track Wise system, ensuring timely opening and closing.Open and manage the CCF pertaining to the department.Collaborate with the Quality System Department in reviewing SOPs in compliance with GMP, regulatory requirements, and corporate guidelines.Execute training for department staff and management through the computer system.Build, review, approve, track, and present documents and procedures required for compliance with pharmaceutical regulations.Identify non-compliance areas, review recommendations, and implement solutions to resolve major quality issues.Manage internal audits, customer audits, regulatory audits, and customer visits.Support actions for operational improvements and efficiency with a focus on continuous improvement and Operational Excellence.Train personnel according to specific Job Descriptions and monitor their activities.Provide support and actively participate in internal and external meetings/calls.Assist in ensuring that downstream manufacturing modules operate efficiently and meet timelines according to SOPs.Apply risk management principles.Collaborate 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 fields.Ability to work in a fast-paced environment under pressure and multitask.Proficiency in Italian and English.Strong interpersonal and influencing skills – written and verbal.
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