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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 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;

Hospital & Health Care - Karachi, Pakistan

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