Loading job details…
Concord Stem Cell Ltd.Verified
Chakrie never asks for money to apply. Report any employer who does.
Bachelor’s/Master’s degree in Pharmacy from a reputed university.
Good understanding of cGMP, QMS, SOP compliance, and documentation practices.
Knowledge of Deviation, CAPA, Change Control, Risk Management, and Audit processes.
Understanding of data integrity and ALCOA+ principles.
Knowledge of aseptic processing, contamination control, and environmental monitoring will be an advantage.
Strong attention to detail and documentation skills.
Good analytical and problem-solving abilities.
Good communication and interpersonal skills.
Ability to work independently as well as in a cross-functional team.
Strong commitment to quality, compliance, and patient safety.
Job Summary:
Concord Stem Cell Limited is seeking a Senior Executive Quality Assurance to ensure quality and regulatory compliance within our cGMP laboratory for all sorts of autologous and allogeneic cell-based and cell-free product processing. The selected candidate will be responsible for monitoring compliance with cGMP requirements, maintaining quality documentation, reviewing laboratory and processing records, managing quality events, and supporting continuous improvement of the Quality Management System (QMS). The candidate will also provide QA oversight of patient-specific therapeutics processing activities, ensuring proper identification, traceability, documentation, and control throughout the processing workflow.
Key Responsibilities
Ensure laboratory and operational activities comply with cGMP, approved SOPs, and company quality procedures.
Monitor day-to-day QA compliance and identify quality gaps, risks, and non-compliances.
Implement and maintain the Quality Management System (QMS) within the laboratory.
Review and control GMP documentation, including SOPs, batch/processing records, logbooks, forms, protocols, and reports.
Ensure compliance with Good Documentation Practices (GDP), Data Integrity, and ALCOA+ principles.
Provide QA oversight of cell-based and cell-free therapeutics processing activities from sample receipt through processing, storage, and release/clinical use, as applicable.
Ensure proper patient/sample identification, traceability, Chain of Identity (CoI), and Chain of Custody (CoC) throughout the respective workflows.
Ensure effective controls to prevent patient/sample mix-up, misidentification, and cross-contamination.
Review processing records and ensure all required quality and documentation requirements are completed before product disposition/release.
Manage and support investigation of deviations, incidents, non-conformances, OOS/OOT, CAPA, and Change Control.
Conduct/support internal / external audits, and regulatory inspections, and ensure timely follow-up and closure of observations.
Support root-cause analysis, CAPA effectiveness monitoring, quality improvement, and GMP training.
Work at office
Full time
Dhaka
Applications for this job are handled on the company's own website.
