Job title: QA Validation Officer
Location: Cairo Site
Hiring Manager: Quality Assurance Validation Section Head
About the job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Job Purpose:
To ensure that all validation activities comply with regulatory requirements, industry standards, and company policies to guarantee product quality and patient safety.
Tasks and Responsibilities:
Issuing & following up of Validation Master Plan (VMP):
Issuing the VMP.
Archiving of finished document with necessary attachments.
Following up & updating implementation by various departments ·
Performing of Manufacturing, Packaging Processes Validation:
Reviewing of updates in current SANOFI guidelines to check for changes.
Creating of validation protocols to include validation 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.
Preparing of the report showing the results of cleaning validation
Reviewing of GMP documents:
Reviewing Master BMRs SOPs, etc... & Ensuring the HSE approval if required.
Updating our GMP documents according to the last updated |GQDs directives & guidelines.
HSE:
Follow the laboratory safety procedures o 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
Others:
Perform other duties as assigned. o 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.
Requirements/Qualifications
2-5 years of related experience
preferred bachelor's degree in Pharmaceutical Science
Soft skills ·
Good communication & Presentation skills.
Planning & organizing skills. · Problem solving skills.
Report writing skills.
Ability to co-ordinate several inter-departmental activities.
Good command of MS Word, Excel & Power Point.
Technical skills ·
Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
Languages · English · Arabic
Play To win Behaviors:
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
Pursue Progress. Discover Extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
