What You Will Achieve
- You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will be responsible for the evaluation, review, and approval of the 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, review, and approval of for validation process documents and technical reports related to equipment, products, and processes.
As an associate, your focus on the job will contribute to 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.
PFIZER job responsibilities;
- Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations.
- Knowledge of validation principles and practices related to the following areas: manufacturing process, analytical method, cleaning methods, facility, equipment, instrument, utility system, and CSV systems.
- Conversant with design & working principles of key equipment used in sterile manufacturing –autoclave, tunnel, lyophilizers, homogenizers, filling machine, filter integrity testing devices.
- Well-versed with the Terminal process – design, execution, and review.
- Experience in plant and QC lab operations
- Good document written skills, with the ability to identify issues and recommend actions.
- Bachelor’s Degree
- B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc/BE
- 2+ years of experience in quality assurance and /or validation function of sterile dosage form facility
- 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 the evaluation of data
- Technical writing experience
- Pharmaceutical Industry with laboratory process validation experience
- Working knowledge of equipment qualification and calibration specifically for laboratory equipment
- Knowledge of current validation regulations in the industry.
- cGMPs and FDA, MHRA, TGA, MCC, etc. regulatory guidelines and validation principles
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.