Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard.
What You Will Achieve
In this role, you will:
- Perform Analytical Method Transfer, Analytical Method Validation and Analytical Method verification in accordance to Standard Operating Procedures (SOPs), adhering to ALCOA principles and Data Integrity requirements.
- Use IMEX "way of working" for day-to-day operations, problem solving, escalation and continuous improvements.
- Participate in 5S team initiatives and practice good housekeeping, ensuring all safety procedures are followed
- Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
- Able to assess the impact to products based on compendial monograph changes/updates/introduction.
- Able to support regulatory submissions and queries for post transfer activity.
- Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
- Conduct Laboratory investigations and propose CAPA for the identified root cause.
- Train colleagues in hands on training of instruments and methods written
- Perform review and approval of test results.
- Able to write position paper, protocols, reports and test procedures.
- Ability to handle QTS actions and raise and complete change controls for changes with GMP impact.
- Involve in regular meeting with donating site and facilitate the smooth transfer of the methods.
- Conduct training for fellow QC colleagues on new methods in the laboratory.
- Contribute to the continuous improvement activities in QC laboratory or cross functional teams as nominated.
- Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalation. Support development and implementation of solution.
- Perform cleaning method development and validation.
- Ensure following the site GDP practice on documentation and preparation of document.
- Method verification in accordance to site or pharmacopeia standards and according to schedule.
- Ensure training records are updated and promptly, are correctly filed to reflect current testing capabilities
- Interpret and evaluate data in terms of accuracy, precision, trends and potential Good Manufacturing Practices {also cGMP} impact and recommend appropriate corrective actions.
- Ensure all documentations and quality records are conducted in accordance to Good Manufacturing Practices and Good Laboratory Practices requirements and that they are filed in accordance to existing policies.
- Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements
- 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.
Here Is What You Need (Minimum Requirements)
- Bachelor's degree with any years of experience, or an Associate's degree with 8 years of relevant experience, or a high school diploma (or equivalent) and 10 years of relevant experience
- Demonstrated technical skills in method transfer, method validation and testing.
- Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
- Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.
- Excellent organizational skills and strong ability to multi-task
- Strong written and verbal communication skills
- Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
Bonus Points If You Have (Preferred Requirements)
- Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography) techniques and GC (Gas Chromatography) technique and all other analytical techniques use in the laboratory.
- Proven track record in leading continuous improvement projects
- Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis
- Strong problem-solving skills and attention to detail
- Ability to manage multiple priorities and meet deadlines.
- Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels
- Adaptability and willingness to learn new techniques and procedures
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control