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Senior Pharmaceutical Quality Assurance Specialist

2 weeks ago

Karachi, Sindh, Pakistan beBeeQuality Full time 1,200,000 - 1,500,000
Job Description:

We are seeking a highly skilled Senior Quality Control Analyst to join our team. As a Senior Quality Control Analyst, you will be responsible for ensuring the quality of our products by performing routine testing and maintaining accurate records.

Your key responsibilities will include:

  • Routine Testing of Raw Materials on HPLC and maintaining lab 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.
Required Skills and Qualifications:

To succeed in this role, you will need:

  • A minimum of 6 years of pharmaceutical experience with accountability for cGMP QC Operations and Product Quality in a manufacturing plant;
  • Superb communications—both written and oral skills;
  • ISO exposure and familiarity required; ISO 9001:2015;
  • Utilizing strong organizational, interpersonal and communication skills to plan and accomplish goals;
  • Analytical Instrumentation Knowledge and working command: HPLC/UPLC, Luminometers, Microplate Readers, and/OR UV/VIS i;
  • 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;
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
Benefits:

This is a challenging and rewarding role that offers a competitive salary and excellent benefits package, including:

  • Hospital & Health Care - Karachi, Pakistan