Pharmaceutical Quality Assurance Specialist

1 day ago

Ayala Alabang, National Capital Region, Philippines beBeeQualityControl Full time $60,000 - $90,000
Job Title:
Pharmaceutical Quality Control Specialist
**Job Description:**
The role of a Pharmaceutical Quality Control Specialist is to ensure that the quality control processes are carried out efficiently and effectively in a pharmaceutical laboratory or company. This involves reviewing and verifying QC records, documentation review, and ensuring compliance with cGMP regulations.
**Responsibilities include:**
  • Ensuring reviewed QC records are compliant to methods, specifications and company's applicable SOP.
  • Verifying documentation review is complete in every respect and verifying all results entered the electronic LIMS system.
  • Assuring records of Validation/Method Transfer/Verification and reports are as per protocol and method provided by clients or written by SGS.
  • Ensuring test results are reported appropriately on either a CofA or a RofA depending on the validation/transfer status of the method.
  • Auditing all record books (logbooks), calibration related documents, and other QC documents associated with testing reviewed/approved.

**Deviation and Out-of-Specification Management:**

  • Requesting deviation to be reported or issuing a deviation report in case where method or SOP was not followed as written.
  • Informing analyst or supervisor to initiate out-of-specification and/or issue OOS form in case of OOS which was not noted by analyst.
  • Issuing an audit form noting deficiencies to method and procedures returns the form to analyst for correction according to Data Review SOP Ensures that all valid deficiencies are corrected, escalates all concerns to management.

**Training and Development:**

  • Incumbents are responsible for their own training records according to training SOP.
  • Attending training sessions ensures that training binder is current Has a training record for every SOP version executed if applicable Requests training if work assigned requires knowledge of SOP.

**Quality and Process Improvement:**

  • Revises forms for execution of methods and procedures issues CCR for method change and new worksheet generation.
  • Identifies participates in and sometimes leads operational improvement initiatives.
  • At all times complies with SGS Code of Integrity and Professional Conduct Remains familiar with SGS quality assurance procedures Complies to all SGS QHSE and HR policies and procedures.
  • Performs other related duties may be assigned either in support of departmental goals or for his/her personal or professional training education or development programmed by his/her immediate superior.

**Qualifications:

  • Minimum Bachelor of Science degree in Chemistry required M.Sc preferred.
  • Minimum 5 years' experience working in a pharmaceutical laboratory or company required.
  • Demonstrated understanding of cGMP regulations required Knowledge in compendiums such as USP is required EP preferred JP BP are advantageous.
  • Experience with TrackWise Digital or any other QMS system preferred Working experience with LIMS systems and multiple instrument management software e.g Empower preferred Proficiency in Microsoft Office Suite Word Excel and Outlook required.

**Additional Information:**

  • Strong written verbal communication skills in English B2+.
  • Proven ability to manage coordinate multiple projects in a fast-paced professional environment.
  • Proven time management skills proficient in effectively prioritizing tasks to meet deadlines set by supervisors.
  • Detail-oriented able to identify minor discrepancies.
  • Able willing to learn new skills review of new tests instrumentation and procedures as required.
  • Thorough knowledge of scientific principles pertaining to analytical records reviewed Ability to interpret analyze data draw logical conclusions required.

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