Posted 5 days ago

Operational Quality Assurance Officer

688 GlaxoSmithKline S.A.E. Egypt, Cairo Salam Plant
Remote Full Time

Job description

Scope: Ensure adherence to GMP standards and procedures through independent oversight of GMP processes. Improve the effectiveness of quality in preventing, identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. Maintain presence and be accountable for key quality decision-making or quality escalations. Provide first line support to operational (for example: rapid response to quality issues, provide guidance and coaching) and maintain inspection-readiness through independent checks for both Vs and Non Vs processes. Review/check Quality-related documentation, and provide reports about quality performance against approved standards. Key Responsibilities: In this role, you will be responsible for the following: GMP Compliance & Oversight: Ensure all GMP processes and personnel adhere to current procedures minimising risk of non-compliance and always maintaining inspection readiness Maintain a visible presence across GMP operational areas to support quality issue management. Accountable for key quality decision making across activities such as the initial impact assessment for deviations Conduct spot-checks in Vs and Non VS areas, for example production, warehouse, utilities, and laboratory areas. Ensure adherence to the Quality Oversight program for both VS and Non VS areas and ALCOA+ documentation principles. Cover oversight shifts Monitor facility housekeeping standards and escalate deviations promptly. Oversee the durability and rightness of related risk assessments and quality systems as LC, PCCE, Eject & reject, IPC frequency, …etc. Accountable to manage the rework and reprocess within the site when needed as per QMS requirements. Documentation & Technical Review: Review/ approve quality documents (SOPs, master batch records, BOMs…etc) Review batch documentation for completeness and compliance with approved standards prior to product release Sampling, Testing & Validation: Ensure proper sampling of Retained finished product batches Oversee OQ measures during Routine & validation batches and engineering changes Deviation & Incident Management: Act as QA reviewer in deviations with lead investigator to ensure RCA identification and proper line of sight Handle customer complaints investigations and ensure proper line of sight Report and follow up on incidents/deviations observed during routine production Quality Culture & Training: Responsible for the delivery of Stop for Quality topics Foster a “Quality Starts With Me” culture through coaching and awareness Foster Oversight culture across Vs and Non VS areas. Cross-functional Support: Provide quality input during management monitoring and quality systems( CCRs, Deviations, Customer compliant…etc): Support EHS and GPS implementation across various activities. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: University Degree in Pharmacy. A minimum of one-year experience in the pharma industry. Up to date knowledge of current GMP and EDA Regulatory requirements. Excellent documentation and report writing skills. Validation knowledge and strong experience in cGMP/GLP compliance activities. Good Computer and communication skills (Word and Excel). Knowledge of EHS and GMP requirements. Fluent in Arabic and English (both written and spoken). Soft Skills: Excellent verbal and written communication skills. Self-motivation, empowerment and adaptation to business changes. Strong prioritization and organization skills. Able to demonstrate experience of managing diverse teams of professional staff and effective budgetary control against agreed targets. This role requires working on a shift-based schedule. Application Closure Date: 19 July 2026 Please submit your CV in English. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Contact information: You may apply for this position online by selecting the Apply now button. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.

Skills and functions

  • Human Resources