Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
- Role: Executive
- Department: QA
- Education: Degree in B.Pharm/M.Pharm/M.Sc
- Experience: 1 – 3 years of experience in Quality Assurance
- Location: India – Vizag
Responsible to review the manufacturing documents
- Fundamental knowledge on manufacturing activities, such as Solution preparation, filling, terminal sterilization/Aseptic, visual inspection, packing, in process sampling and analysis.
- Knowledge in change control assessment
- Responsible for review and approval of equipment qualifications, equipment audit trails and instruments qualifications associated with computers systems.
- Effective communication with all staff from different levels and builds constructive and effective relationship
- Review of product & process related SOP & Forms
- Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values
- Report any non-compliance to the Supervisor
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
In your role, you will be joining a team that is accountable for assuring the compliant validation of information technology systems. Your work will involve creating formal validation documentation (including standard operating procedures) as per governmental regulations and coordinating activities with clients, programmers/developers and operating personnel, in-country or global, as appropriate.
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 focus 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 project tasks and/or milestones.
- Organize own work to meet project task deadlines.
- Collaborate with site and global colleagues on assigned team to ensure completion of projects in a timely manner.
- Provide guidance and Quality oversight of the validation of Automated Systems (Engineering, Manufacturing and Laboratory Equipment and Information Technology) ensuring compliance to applicable regulations.
- Create new Master Data and process changes to existing Master Data of varying technical complexity.
- Process Master Data updates for Change Controls and document updates.
- Provide troubleshooting expertise and support for business unit activities and end users including instrument interfaces in conjunction with the IT Department.
- Aid in interfacing with site personnel on integration of sample management and electronic system processes to ensure optimal laboratory operations.
- Provide hands-on, individual and group training(s) as needed for all user levels and develop training modules/protocols/walk-through guides accordingly.
- Aid in updating corresponding departmental SOP and training materials as needed in accordance with global procedures and processes, as requested.
- Support training of new team members of the team.
Qualifications
Must-Have
- Degree in B.Pharm/M.Pharm/M.Sc
- Experience in pharmaceutical industry: 1 – 3 years of experience in Quality Assurance/Manufacturing of sterile dosage forms.
- Experience in Quality administered systems
- Sound knowledge of current Good Manufacturing Practices {part of GxP}
- Ability to work in a team environment within own team and interdepartmental teams
- Effective written and oral communication skills
Nice-to-Have
- Preferred experience in Computer systems or manufacturing equipments having computerized systems.
- Demonstrated capability to work as a team member in a matrix environment.
- Fundamental knowledge of the principles and concepts of QA.
- Advanced computer skills.
- Ability to work independently and multi-task in a fast, priority switching environment while demonstrating a positive attitude.
- Strong reading, comprehension and proof reading skills, strong organizational skills.