CONTRACT MANUFACTURING QUALITY SPECIALIST(Temporary)

QUALIFICATIONS

Education
Graduated with an university degree, preferably from Chemistry, Chemical Engineering, Industrial Engineering, Pharmacy, Biology departments, 
 
Experience
Relevant experience in pharmaceutical industry, manufacturing and quality experience
 
Knowledge and qualifications

• Advanced level of written and verbal English communication skills
• MS Office use skill
• GMP knowledge, Ministerial correspondance skill, Legislative Scrunity

 Competencies

• Project management
• Good communication and organization skils ( with internal & external partners)
• Teamwork skills
• Working in a planned manner
• Result oriented working
• Customer Focus, Innovative Thinking
• Analytical Thinking
• Attention to details
• Ability to deal with ambiguity

 

 

İŞ TANIMI

JOB DESCRIPTION

Quality Management System

1. Quality Documents

Ensure a consistent management of country Quality Documents related to GMP activities within the country using the appropriate tools:

• Maintain an updated mapping of GMP Quality Documents within the Turkey Organization
• Ensure that the mandatory local procedures are in place/in use at both Sanofi Turkey and CMO levels

Assist in the issuance of Quality Standard Operating Procedures and their related training
Ensure GMP aspects of product manufacturing are reviewed versus established Quality Standards

2. Deviations Management and Corrective-Preventive Actions (CAPA) Management

• Ensure that the investigation and management of deviations as well as the Out Of Specifications arising at the CMO’s are handled in alignment with GMP

3. Change Management

• Manage the changes that may impact GMP processes or operations by following multidisciplinary exchanges and action plans as applicable

4. Audit and Inspection Readiness

• Support in the quarterly running of the Inspection Readiness Tool
• Support in any audit or inspection preparation and related follow-ups and CAPAs

5.Internal and Country Reconciliation

• Support in the initiation and management of the internal and country reconciliation to cover Medical Information, Pharmacovigilance, Product Technical Complaints and Counterfeit
• Ensure proper documentation and tracking of this procedure
   

6.Trainings

• Perform routine Quality trainings to GxP departments, according to the established training plan

7.Country quality performance indicators (QPIs):

• Maintain an efficient tracking system across all Quality activities to allow an easy data extraction and analysis related to Country QPIs
• Periodically report country QPIs defined by the operational quality unit in charge of the Turkey organization (in addition to any other locally defined quality indicators)
• Follow-up with GxP departments on their specific QPIs

8.Country Quality Review

• Assist in the data collection, analysis and preparation of the Country Quality Review presentation and report

 
Product Quality

Ensure GMP compliance of products fully manufactured and packed by the Contract Manufacturing Organizations (CMOs):

9.Product transfer activities

• Follow-up of product transfer activities, set bridge between with Sanofi Sites and contract manufacturers.

• Manage quality documentation related transfer activities

• Perform regular meetings/TCs with Sanofi Sites and contract manufacturers 

10. Product Technical Complaints (PTCs)

• Manage PTCs received by the country organization related to locally manufactured products according to defined Quality Standards & processes and in connection with Global Quality Functions (PTC global database) and other relevant units
• Manage PTCs reported on raw material and semi-finished products by the CMOs
• Ensure follow-up on pending cases until their closure 
• Update PTC tracker in a timely manner
• Maintain an adequate documentation and filing system
• Conduct PTC trend analysis and signal detection, as appropriate  

11. Temperature Excursions 

• Manage Temperature Excursions related to the inbound shipments of raw material and bulk products and their local storage in accordance with the established flows and processes
• Provide release decision in alignment with the Country Quality Head 
• Ensure follow-up on pending cases until their closure 
• Track the Temperature Excursions in a timely manner

12.Product Related Quality Events

• Assist the Country Quality Head in any product related quality event / alert across countries from its identification, tracking and reporting until its closure

13.Product Quality Reviews

• Review and assess the Product Quality Reviews drafted by the CMOs

Ensure the compliance to the planned activities by the CMOs
 

Third Party Management

14.Third Party Quality Oversight

• Ensure an appropriate quality oversight process of locally managed CMOs, either directly (being involved on selection process, qualification and performance of audits) or through coordination with the concerned country functions (as appropriate)
• Ensure that the CMOs are respecting the contractual clauses of the Quality Agreement
• Monitor contractor compliance via GxP documentation review and on-site visits/audits
• Ensure that the batch release of the finished products is managed by the CMOs in accordance with the specifications, Sanofi and the Quality Agreement’s requirements
• Ensure the completion of the Annual Site Quality Review for the CMOs

15..Quality Agreements 

• Assist the CQH in the review and implementation of the Quality Agreements with the CMOs and the Sanofi Manufacturing Sites, where required 

16.Third Party Reconciliations 

• Assist with the initiation and management of the Third Party reconciliation to cover Medical Information, Pharmacovigilance, Product Technical Complaints and Counterfeit
• Ensure proper documentation and tracking of this procedure

17.Audits 

• Ensure that CMOs are risk assessed on a continuing basis and corresponding audit frequency is defined, included into the country annual audit plan and respected
• Follow-up on the implementation of the yearly audit plan

 18.Quality Alert Management

• Assist the Country Quality Head in the escalation of any risk identified at CMOs’ level
• Assist in the investigation of the risk and follows-up with the defined action plan
• Suggest and implement new initiatives aiming at continuouslyimproving Quality awareness at local level  

Quality Culture

• Ensure appropriate communication of key messages pertaining to quality across the organization, highlighting their possible business impact
• Assist the CQH in drafting and performing quality related trainings for the countries 
• Suggest and implement new initiatives aiming at continuously improving Quality awareness at local level