QA Validation Specialist At Sanofi Egypt
JOB PURPOSE:
Assurance of the validity of various GMP related processes to ensure their consistency & reproducibility through planning & performing all validation activities in coordination with various departments involved.
KEY RESPONSIBILITIES AND DUTIES:
Issuing & following up of Validation Master Plan (VMP):
Issuance of VMP.
Archiving of finished document with necessary attachments.
Following up & updating implementation by various departments
Performing of Manufacturing, Packaging Processes Validation:
Review of updates in current SANOFI guidelines to check for changes.
Creation of validation protocols including objective, scope, responsibilities, critical parameters, acceptance criteria, sampling locations to be conducted during validation.
Monitoring & checking the various activities during production processes & ensuring that they are as mentioned in both Processing batch record & validation protocol.
Sampling according to validation protocol & providing QC with samples.
Collecting data from the various departments, analyzing information provided & preparing report to include results & conclusion of validation.
Performing of Cleaning Validation:
Studying the design of the machines &determine the critical points for cleaning.
Initiating the protocols & follow up distribution to concerned department after approval of concerned managers.
Following up of sampling process & Revising data.
Preparing of the report showing the results of cleaning validation.
Performing of Media Fill Test:
Reviewing of media fill protocol.
Monitoring & checking of the various activities during media fill & ensuring that they are carried out as mentioned in the media fill protocol.
Collecting data from the various departments, analyzing information provided & preparing media fill repot to include results & conclusion of the media fill.
Reviewing & Updating of GMP documents:
Updating of Master BMRs SOPs, etc... & ensuring the HSE approval if required.
Updating our GMP documents according to the last updated |GQDs directives & guidelines.
HSE & Others
Follow the laboratory safety procedures
Commitment to the appropriate PPE use.
Follow the approved HSE policy and requirements.
Following the statutory legislation concerning Health, Safety and environmental law.
Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system
Perform other duties as assigned.
Respect of company’s values, code of ethics and social charter.
Respect of personal data protection charter.
Responsible for applying the HSE related requirements for the company in all related working procedures.
JOB-HOLDER’s ENTRY REQUIREMENTS
Education
Bachelor of Pharmaceutical Sciences.
Related Experience
3 - 5 years` experience in related quality assurance function.
Special Knowledge/Skills
Good Communication skills with ability to co-ordinate several inter-departmental activities.
Presentation skills
Computer skills (Good command of MS office)
Sense of urgency
Follow up skills
Time management skills
High organization & planning skills
Good Command of English Language,
Attention to Details
Hard Worker and Team Worker
Problem solving skills.
Report writing skills.
Validation theories, methodologies & sampling techniques.
Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
SANOFI guidelines & standards.
Competencies
Stretch to go beyond the level we have operated at up until now
Take actions instead of waiting to be told what to do
Act in the interest of our patients and customers
Put the interests of the organization ahead of my own or those of our team
Act for Change, strive for results, Cooperate Transversally, Commit to Customer
Think Strategically, Lead Teams, Develop People, Make Decisions