القائمة الرئيسية

الصفحات

QC Validation & Compliance Section Head At Sanofi

QC Validation & Compliance Section Head At Sanofi

JOB PURPOSE:                  

Responsible for supervision all the validation activities (process , Analytical method validation and cleaning validation )  

Responsible for continuous availability of All QC instruments / Equipment required for QC Chemical & Microbiology laboratories Analysis activities and to maintain their compliance to HSE, cGLP, and regulatory requirements in addition to guarantee full compliance with company policies, guidelines, & data integrity.

JOB RESPONSIBILITIES: 

Responsible for controlling and follow up of process validation, method validation, and cleaning validation analysis process and its relevant documentation (Protocols & reports) insuring their compliance to cGLP & GDP at the specified timeline


Supervise analytical method validation, analytical transfers, cleaning validation and process validation plans and implementation


Perform Equipment Qualification / calibration process for all QC equipment according to pre-defined annual plan.


Conduct Semi-annual QC Qualification / Calibration plan assessment to determine efficiency & adherence of the set plan.


Responsible for all tasks related to caducee regarding technical issues , adding or deleting users , Including any new CDS systems in the Caducee , any compliance issues or audits requirements related to Caducee


Follow up outsourcer’s calibration schedule for Q.C equip. related to Quality Eng. and/or agents.


Insure complete adherence to calibration due dates & takes actions in case of OOC situations with relevant agent.


Set up preventive maintenance program for Q.C CDS according to the valid contracts, and Implementation of Preventive maintenance program.


Implementation of GLP Self-inspection monitoring on Monthly basis to cover both practical & documentation process & report deviation to Q.C manager.


Monitoring of Lab equipment performance through logbooks for usage & calibration.


Issue & Update of All Q.C Equipment SOP ((Chemical Labs SOPs only (Main & Cephs-lab)).


Follow up of Quality Control LEAN program and integration of the QC LEAN activities with the site LEAN program.


Determination of Analysis requirements for new materials & new products as per the documents submitted by IA Portfolio Management as well as their relevant purchasing requests (PR) & their receiving.


Implementation of HSE Self-inspection monitoring on Monthly basis, and recording of HSE deviation for all Q.C Labs.


Support in quality control  CAPEX Plan, prepare URS, & request offers for technical comparative study with Q.C manager.


Support for the QC manager for Order,  and receiving Quality CAPEX items Conduct On job training plan for newly recruited analysts and insure their compliance with cGLP & GDP


Lead QC Validation team and set up their annual priorities including individual development plans to support continuous improvement programs.

JOB QUALIFICATIONS: 

Education:

Bachelor degree in Pharmaceutical Science, or Science.

Related Experience:

7 - 10 years in related position, preferably in multinational company.

Special Knowledge/Skills:

Good Interpersonal & communication skills.

Good technical, managerial, & Leadership skills.

Sufficient quality practices (GMP, GLP).

High sense of urgency.

High organization & planning skills.

Good Command of English Language.

Good computer skills.

Familiar with new instrumental analysis techniques

 Apply Here

reaction:

تعليقات