Job Description

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 meets the highest standards of safety and efficacy.

The incumbent is a member of the Quality Control (QC) Laboratory team. Under the supervision of the QC Manager / Supervisor, the key responsibilities are:

• Review and approval of QC sample/lot disposition in the QC Laboratory.

• Work with the different QC teams to ensure products are tested and released within the stipulated timeline.

• Conduct and support laboratory investigations.

• Author annual LIR trend report and Annual Product Record Review (APRR).

• Represent QC to participate in monthly EHS safety meeting and be the QC lead to drive the safety culture in QC laboratory.

• Set up and maintain QC processes (e.g. Sample lot disposition, reference standard and retention samples management). Author SOPs other GMP documentation

• Use Imex "way of working" for day-to-day operations, problem solving, escalation and continuous improvements.

What You Will Achieve

In this role, you will:

• Perform quality review of completed Laboratory Information Management System (gLIMS) test records ensuring strict adherence to ALCOA principles and Data Integrity (DI) requirements.

• Perform Approval of QC samples/Lot disposition in the gLIMS and release of API, intermediates, raw materials, solvents and packaging materials.

• Ensure prompt approval of QC samples as per Service Level Agreement for the different products and escalate any potential delay to the different functions.

• Conduct laboratory investigations regarding testing, reference standards and API release where required and ensure all follow-up actions are completed.

• Collaborate with internal stakeholders and author annual LIR trend report and Annual Product Record Review (APRR).

• Represent QC in New Product transfer meeting to ensure all operational issues noted are escalated and resolved.

• Represent QC to participate in monthly EHS safety meeting and be the QC lead to drive the safety culture in QC laboratory.

• Lead and maintain 5S culture, practice good housekeeping and ensuring all safety procedures are followed.

• Perform change management activities if required.

• Provide guidance and support fellow teammates in the management of retention samples, reference standards, laboratory chemicals and supplies in accordance to site SOPs.

• Author SOPs and other GMP documentation.

• Conduct training for fellow colleagues.

• Uphold Pfizer's code of conduct and values.

• Lead continuous improvement activities and collaborate with cross-functional teams to drive flawless execution.

• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalations. Support development and implementation of solutions.

Here Is What You Need (Minimum Requirements)

• Effective planning, organization and time management skills.

• Effective problem-solving skills.

• Demonstrated leadership and interpersonal communication skills.

• Team player and action oriented.

• Knowledge of cGMPs and ALCOA principles.

• Possess a can-do / pride to succeed attitude.

• Experience in gLIMS/SAP

• Proficiency in data analysis and interpretation

• Knowledge of regulatory requirements and guidelines

• Embrace the use of digital technology to scale and speed up every form of interaction and action.

Qualification

• Degree in Science (Pharmaceutical Science / Chemistry / Molecular Biology)

Experience

• A minimum of 5 years QC experience in the pharmaceutical industry.

Work Location Assignment: On Premise

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.

Quality Assurance and Control