Quality Control Analyst - Pfizer

Position summary: describe in one or two sentences the primary purpose of the job

• Conduct routine and non-routine analyses and relevant documentation and reporting.
• Performance of lab-related tasks.

Job Description and tasks:

• Conduct routine and non-routine analyses of in-process materials, finished goods, or stability samples in a timely manner.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• Conduct chemical or physical laboratory tests in making qualitative or quantitative analyses
• Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
• Write technical reports or prepare graphs or charts to document experimental results.
• Calibrate, validate, or maintain laboratory equipment.
• Participate in out-of-specification and failure investigations and recommend corrective actions.
• Supply quality control data necessary for regulatory submissions.
• Investigate or report questionable test results.
• Addition and withdrawal of stability samples from stability chambers
• Performance of data entry and trend analysis
• Reviewing, filing, reporting and trending of stability data
• Perform the Analytical Method Transfer Exercise (AMTE) for the new test procedures required for manufacturing of new product in our site.
• Perform Validation required for the new developed test procedures.
• Execute all activities related to process, cleaning and instrument validation.
• Preparing and executing the SOPs, calibration and validation documents (IQ, OQ & PQ) related to chemical laboratory tasks.
• Implementing the PQS requirements regarding the chemical laboratory
• Using, monitoring and controlling Reference standards inventory and expiry
• Using, monitoring and controlling of expiry and inventory of laboratory stock items including reagents, glassware, filters, etc.
• Perform Data loggers monitoring, downloading and reviewing
• Writing and revision of Quality Control SOP’s
• Working on improving his process by implementing lean and 6σ projects.
• Responsibility for implementation of Data integrity program in the relevant work area and Insure following up ALCOA principles all over operations.
• Active implementation of Notification to Management procedures.
• Responsibility for compliance with Pfizer Quality Standards.

Experience and Knowledge 

• cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.
• Knowledgeable with basic Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.
• Responsible for insuring that all results generated are in compliance with data integrity requirements.
• Responsible for raising “NTM” Notification to Management whenever condition in PQS Q1213 applies.

Essential Personal Qualifications

• Bachelor’s degree in Pharmacy or Scientific background
• High physical and technical skills
• Good command of English language
• High observation skills
• Familiar with MS Word, MS Excel and basic statistics (mean, SD, %RSD).
• Has the ability to work under stress
• Good looking, Pfizer imaging

Preferred Qualifications

• Two (2) years’ experience is preferred in a related area.
• Highly motivated towards achievement and task oriented.
• Ability to effectively organize and manage personal work schedule semi-independently.
• Active listening.
• Hard worker & self-motivated.
• Time management skills.

Apply Here