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 and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. In consultation with Clinical R&D management, you will be responsible for establishing practices and procedures that comply with regulatory agencies and be ready for corporate level audits by performing detailed internal audits at Pfizer’s clinical research and development sites to ensure compliance. Your in-house audit reports will ensure that appropriate corrective actions are recommended to address any weaknesses, ineffective procedures, policy exceptions and discrepancies.
As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements and providing areas of improvement for products, processes, or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
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
- Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the division.
- Assess compliance of clinical investigator sites, vendors, study activities, pre-clinical research activities, data and reports, submissions and processes against applicable government agency/Pfizer regulations/guidelines.
- Conduct audits of clinical investigator sites, nonclinical laboratory studies and vendors. Communicate findings to project team personnel and management, interact with various teams to ensure corrective actions are taken to bring QA observations to closure as applicable.
- Assure product compliance through timely and accurate maintenance of Chemistry Manufacturing and Controls (CMC) submission documentation and product knowledge in Regulatory systems.
- Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.
- Develop implementation guidelines, task ownership matrices and process maps for implementation of SOPs.
- Identify and initiate ways to improve internal quality and compliance reviews and processes.
- Assist in the development and implementation of appropriate SOP training curricula and ensuring training compliance in the appropriate site system.
Qualifications
Must-Have
- Bachelor’s Degree and 5+ years of experience.
- Comprehensive working knowledge of Quality Assurance, regulations and auditing.
- Knowledge of quality system and document requirements.
- Strong verbal and written communication skills
Nice-to-Have
- Master’s degree and relevant pharmaceutical experience.
- Experience with SOP (Standard Operating Procedures) and training implementation.
- Skills in document manipulation and electronic document maintenance.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
