Senior Quality Control Analyst

4 weeks ago

Karachi, Sindh, Pakistan Akhai Group Full time

Routine Testing of RAW Material on HPLC and Maintain Lab record.

Assists in performing validations.

Reviewing test method results for conformity to specification and reporting on quality discrepancies.

Monitor 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.

Collaborate with Contract Test Laboratories and other outside entities.

Coordinate receipt, tracking, storage, shipment and distribution of Stability, Raw Material and In-process QC samples.

Assist with internal audits.

Support creation and revision of Raw material specifications and risk assessments.

Recognize, report, and document deviations from SOPs, test methods and specifications.

Job Specification

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.

Utilizes 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.

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.

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