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

Your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
 
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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

The primary purpose of this position is to provide leadership and direction to the QC Laboratory Data Integrity Team. The role is accountable to manage data integrity, investigation, personnel training, laboratory documentation, laboratory equipment qualification, calibration and computerized system validation and gap analysis against Pfizer Quality Standard/cGMP and all GMP-related records in QC Laboratory

How You Will Achieve It

• Drive team engagement and effective communication within QC Laboratory Data Integrity Team
• Actively coordinate with the teams to ensure the project (i.e. laboratory equipment qualification, etc.) in QC Laboratory are delivered in the most effective way and meet target dates
• Maintain and ensure compliance in Quality and Safety such as submitting CASR, QAR/ER, safety incident and CAPA as per committed in QC Laboratory
• Review and approve protocol and report of qualification of laboratory instrument
• Guide and accompany analyst during qualification of laboratory instrument
• Review computerized system validation result in the QC Laboratory 
• Perform periodic review related to audit trail, user privilege, back-up, restore and data integrity gap assessment for instrument and QC documents 
• Hold and maintain administrator account in equipment and instrument in QC Laboratory
• Maintain QC Laboratory documentation and doing Laboratory investigation, Manufacturing investigation and closure of all commitments.
• Manage calibration activities and review calibration/verification report
• Manage curricula and training assignment, and ensure training completion in QC Laboratory
• Revise SOP, STP and other GMP document in QC Laboratory, as required
• Perform training to QC Laboratory Personnel, as required

Qualifications

Must-Have

• Graduate from Faculty of Pharmacy or Chemical Science (S1, Undergraduate Degree)
• 3+ years’ experience
• Laboratory supervisory experience
• Knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories
• Experience with leading colleagues and/or projects
• Strong people management experience
• Demonstrated skills in collaboration, attention to detail, and communication skills
• Ability to handle complex and detailed situations with a focus on quality

Nice-to-Have

• Master's degree
• Six sigma certified
• Relevant pharmaceutical experience.
• Experience with microbiological risk assessments
• Knowledge of Laboratory Information Management System Empower and Microsoft Office
• Working knowledge and understanding of requirements as it relates to method qualification and testing of components and finished products

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

We welcome applications from candidates of diverse abilities and backgrounds. People with disabilities are encouraged to apply. If you need accommodations to participate in the application process, please inform us. Our commitment is to establish an inclusive and accessible workplace for everyone.

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 evaluate and review Pfizer’s product labels. Your expertise will help in identifying deviations from established standards, in the artwork and packaging development of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

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

• 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.
• Create, review and approve Good Manufacturing Practices documents of artwork related.
• Create, review and approve deviations and consistently produce quality work.
• Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
• Assist and support the packaging staff in detecting and solving compliance errors in real time during packaging operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.

Qualifications

Must-Have

• Bachelor's Degree
• Ability to work in a team environment within own team and interdepartmental teams.
• Effective written and spoken communication skills (English and Indonesia Language)
• Experience in design software.

Nice-to-Have

• Experience in Quality systems related with packaging development
• Experience of writing and managing deviations
• Experience in ERP system, investigation of non-conformance, root cause analysis and change control management.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.