Senior Quality Control Analyst
2 weeks ago
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 SpecificationA 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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