Regulatory Sciences GMP Specialist (Contractor)

Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
Responsibilities

• GMP submissions of pipeline products
• Coordination of the inspections with the sites and the inspectors
• Communication with the authority regarding GMP related issues
• Attend GMP inspections as Pfizer Turkey representative when needed
• Submissions for GMP renewals of previously inspected sites
• Follow up any changes occurring at the sites and inform the authority accordingly.
• Keep the archive, systems and tracking tools updated at all times
• Coordinate regulatory activities of specific products if needed

Qualifications

• Scientific degree from Pharmacy, Biology, Chemistry or Chemical Engineering departments
• 1-2 years experience of TITCK GMP processes
• Have a good command of written and spoken English
• Have good organization skills
• Good detail-capturing skills while working in a fast moving environment.
• Be computer literate (Word, Excel, PowerPoint, MS Project, Acrobat, INTERNET, INTRANET,etc.)

Organizational Relationships

• Regulatory Affairs Department
• Planning and Procurement Departments
• Manufacturing sites
• GRRS

#LI-PFE
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
School of Leaders
We, as Pfizer Turkey, make a difference with our visionary and pioneering approaches ranging from our concept of raising leaders through rotations, providing international career opportunities to creating a flexible, enjoyable work environment. There are no limits to what we can accomplish to touch lives here!
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Regulatory Affairs