Senior Quality Assurance Specialist

2 weeks ago

Karachi, Sindh, Pakistan beBee Careers Full time

Routine Testing of RAW Material on HPLC and Maintain Lab record is an essential responsibility.

We are seeking a skilled Senior Quality Control Analyst to join our team.

This role involves assisting in performing validations; reviewing test method results for conformity to specification and reporting on quality discrepancies; monitoring critical operating parameters for laboratory equipment and instrumentation; processing non-conformances as needed; timely reporting and analysis of stability results to support initial expiry setting and expiry extensions; stability, raw material and sample management program/process continuous improvement; collaborating with contract test laboratories and other outside entities; coordinating receipt, tracking, storage, shipment and distribution of stability, raw material and in-process QC samples; assisting with internal audits; supporting creation and revision of raw material specifications and risk assessments; recognizing, reporting and documenting deviations from SOPs, test methods and specifications.

Job Responsibilities:
  • Routine testing of raw materials on HPLC
  • Maintaining lab records
  • Assisting in performing validations
  • Reviewing test method results
  • Reporting on quality discrepancies
  • Monitoring critical operating parameters
  • Processing non-conformances
  • Timely reporting and analysis of stability results
  • Stability, raw material and sample management program/process continuous improvement
  • Collaborating with contract test laboratories
  • Coordinating receipt, tracking, storage, shipment and distribution of stability, raw material and in-process QC samples
  • Assisting with internal audits
  • Supporting creation and revision of raw material specifications
  • Recognizing, reporting and documenting deviations from SOPs
Requirements:
  • A minimum of 6 years of pharmaceutical experience
  • Accountability for cGMP QC operations and product quality in a manufacturing plant
  • Superb communications skills
  • ISO exposure and familiarity required; ISO 9001:2015
  • Utilizes strong organizational, interpersonal and communication skills
  • Analytical instrumentation knowledge and working command: HPLC/UPLC, Luminometers, Microplate Readers, and/OR UV/VIS
  • Team-oriented approach to project management and problem resolution
  • Priority will be given to candidates with direct experience in stability and raw materials
  • Bachelor's degree required; preference given to candidates with advanced degrees and degrees in chemistry or a biological science
  • Thorough knowledge of cGMPs, ICH, USP/EP/JP and global regulatory requirements
  • Knowledge of test procedures and instruments for stability and raw material testing program
  • Strong organizational skills

We offer a collaborative team environment where you can apply your expertise and passion to make a difference.

You will have the opportunity to work with a talented team of professionals who share your commitment to excellence.

If you are a motivated and detail-oriented individual with a passion for quality control, we encourage you to apply.

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