Quality Control Specialist

7 days ago

Karachi, Sindh, Pakistan beBee Careers Full time
Quality Control Specialist

As a Quality Control Specialist, you will be responsible for ensuring the quality of raw materials and products in a manufacturing plant.

Key Responsibilities:
  • Routine testing of raw materials on HPLC and maintaining laboratory records.
  • 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.
Requirements:
  1. A minimum of 6 years of Pharmaceutical experience with accountability for cGMP QC Operations and Product Quality in a manufacturing plant.
  2. Superb communication skills, both written and oral.
  3. ISO exposure and familiarity required; ISO 9001:2015.
  4. Utilizing strong organizational, interpersonal, and communication skills to plan and accomplish goals.
  5. Analytical Instrumentation Knowledge and working command: HPLC/UPLC, Luminometers, Microplate Readers, and/OR UV/VIS.
  6. A team-oriented approach to project management and problem resolution.
  7. Priority given to candidates with direct experience in Stability and Raw Materials.
  8. Bachelor's degree required; preference given to candidates with advanced degrees and degrees in Chemistry or a biological science.
  9. Thorough knowledge of cGMPs, ICH, USP/EP/JP, and global regulatory requirements.
  10. Knowledge of test procedures and instruments for stability and raw material testing programs.
  11. Strong organizational skills.
  12. A highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.

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