Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will be responsible for create, update and revise of validation master plan, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing for validation process and system qualification documents.
As an validation specialist, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Determine process capability of new equipment through execution of approved protocols and assure defined parameters are incorporated into respective operating procedures and batch records.
- Assists with development of validation protocols and manage Regulatory queries and responses.
- Participate in deviation investigations to identify root causes and define corrective and/or preventative actions.
- Adhere to all company and Good Manufacturing Practices {also cGMP} procedures, along with safety regulations within the plant and participates in developments of validation programs as needed to remain current with cGMPs and industry.
- Work effectively as a member of the Quality Operations (QO) Good Manufacturing Practices {also cGMP} training team as well as directly with Business Area Training Leads / Coordinators and SMEs within Quality to support Good Manufacturing Practices {also cGMP} and site training initiatives.
- Work on summarization of data into concise reports that is reviewed by the QO product professional and approved by production and quality management.
- Define problems, collect data, establish facts, and draw valid conclusion.
- Work in a team environment to meet all team objectives and communicate progress on scheduled projects.
Qualifications
Must-Have
- Bachelor's Degree
- Excellent attention to detail and working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices
- Excellent organizational skills, and ability to handle changing deadlines.
- Strong communication with written and verbal skills
- Working knowledge of Microsoft Office, especially Excel for evaluation of data
Nice-to-Have
- Technical writing experience
- Pharmaceutical Industry with manufacturing and packaging process validation experience
- Pharmaceutical Industry with cleaning process validation experience
- Working knowledge of equipment qualification and calibration specifically for production and laboratory equipment
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
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