Laboratory Specialist

4 days ago

Jakarta, Indonesia Pfizer Full time

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

As laboratory compliance specialist, 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

The role is accountable to manage compendia compliance, laboratory documentation, method validation/ verification activities, and ensure that current GMP practice in QC Laboratories comply against Pfizer Quality Standard/cGMP, not limited to:

- Assist Quality Process Improvement Manager and/or QC Lab Compliance Supervisor for writing or updating Standard Operating Procedure (SOP) and Standard test procedures (STP) in accordance with actual practices, PQS, current GMP, and regulatory requirements, in QC Chemical Lab
- Execute the project (i.e method validation/verification, etc.) in QC Laboratory Compliance Team in the most effective way and meet the target date
- Ensure all reagent, reference standards, and equipment are ready for testing
- Manage the method validation and testing execution by external lab
- Prepare analytical method validation/ verification protocol and report, and study in QC Chemical Lab
- Support QC Lab Compliance Supervisor to manage and maintain the implementation of compendia compliance in QC Area
- Ensure the compliance in Quality and Safety by such as submitting safety incident and complete CAPA as per commitment date
- Manage change control related to process and documentation for laboratory compliance activities
- Maintain QC Laboratory documentation (including registration dossier related to laboratory document) in QC Chemical Lab
- Support team to conduct and prepare laboratory investigation and manufacturing investigation report
- Perform training to QC Lab personnel, as required

**Qualifications**:
Must-Have
- Bachelor's Degree (Chemistry or Pharmacy)
- Min 1 year experience in analytical method development/validation will be preferred
- Strong knowledge about analytical instruments and various test procedure, including as in most current compendia (FI, USP, BP, etc.)
- Knowledge of regulatory compliance requirements for Pharmaceutical manufacturing
- Good analytical thinking and high-level integrity
- Able to work well either as an individual or as a team member
- Excellent interpersonal and communication skills

Nice-to-Have
- Good knowledge of dossier and product registration process
- Familiar with stability study and testing
- Experienced in computerized system, such as Laboratory Information Management System

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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