600469 - Associate Validations
2 months ago
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 evaluation, review and approval 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, 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 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
- 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, homogenisers, filling machine, filter integrity testing devices.
- Well versed with Terminal process - design, execution and review.
- Experience in plant and QC lab operations
- Good document written skills, with ability to identify issues and recommend actions.
**Qualifications**:
Must-Have
- 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 evaluation of data
Nice-to-Have
- 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.
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