Laboratory Specialist

Pfizer
Full Time
Jakarta
Posted: 2023-02-19
Daftar Lowongan
Deskripsi Lowongan
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 laboratory compliance team. You will have the all-important role of conducting study and micro method validation to comply with current compendia and Pfizer Standard. You will be relied on to make sure that they comply with the policies, procedures and practices laid down by the regulatory agencies. Your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
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
  • Assist Quality Process Improvement Manager and/or Lab Compliance Supervisor for writing or updating Microbiology Lab’s Standard Operating Procedure (SOP)/ Prosedur Tetap (PROTAP)/ Standard test procedures in accordance with actual practices, PQS, current GMP, and regulatory requirements.
  • Participating in validation and qualification program
  • Develop and/or perform microbiological method validation/ verification in accordance with the approved protocol and provide report.
  • Develop or revise SOP or test procedures in Microbiology Lab.
  • Responsible for creation and maintenance of a Microbiological and Contamination Control Strategy (MCCS) for PGS Jakarta Site
  • Responsible to ensure implementation of MCCS in accordance with local SOP along with system owner
Qualifications
Must-Have
  • Bachelor's Degree in microbiology or pharmacist degree
  • 2+ years' experience. Experienced in microbial method development & validation will be plus
  • Certification in assigned area, if applicable
  • Successful hands-on analytical testing experience in a Good Manufacturing Practices {also cGMP} environment
  • Technical Skills- Knowledge of laboratory equipment, testing and technique
  • Good knowledge and application of data integrity
  • Strong organizational skills and ability to multi-task across projects and activities
  • 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
  • Experience in a pharmaceutical microbiology laboratory
  • Good understanding related to micro contamination in manufacturing process
  • Good knowledge of manufacturing process in pharmaceutical industry

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
#LI-PFE
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