Quality Technical Specialist
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 have the all important role of conducting internal audits of R&D and Quality laboratories, prior to the audit by regulatory agencies. You will be relied on to make sure that they comply with the policies, procedures and practices laid down by the regulatory agencies. Your attention to detail will help us report discrepancies in product safety and recommend appropriate corrective actions. You will help the laboratory management to establish practices and procedures prior to audits.
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 teaming environment for your colleagues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Maintain Laboratory area, equipment, facilities in a clean, orderly and operational state.
- Monitor that all reagents, reference standard are always available and ensure all reagents and reference standards are valid to use and stored according to requirement.
- Perform verification or calibration of instruments/ equipment.
- Support chemical and physical analyses on samples from all areas of our pharmaceutical manufacturing operations and support in providing data for annual product review.
- Develop good working practices/guidelines to work as tools to assist staff in the use of quality system Standard Operating Procedures.
- Manage review and approval of Building Management System Alarms.
- Lead the Continuous Improvement (CI) process for the Integrated Manufacturing Excellence (IMEx) within the Drug Product unit, identify and conduct continual improvement project.
- Consult with managers in various groups to coordinate and implement decisions made regarding compliance practices.
- Build trusted relationship with customers, colleagues in team, cross functions.
- 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.
Qualifications
Must-Have
- Bachelor's Degree
- Good working knowledge of common laboratory databases
- Knowledge of regulatory compliance requirements for Pharmaceutical manufacturing
- Good analytical thinking and high-level integrity
- Familiarity with cGMP, ALCOA & data integrity, cGLP, laboratory equipment/instrument maintenance, calibration and qualification.
- Able to work independently and as a team.
- Understanding of maintenance and reliability concepts.
- Good verbal and written communication skills
Work Location Assignment: On Premise
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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