Operational Quality Officer

20 سبتمبر، 2022

0 44 4 دقائق

الوصف الوظيفي

Site Name: Saudi Arabia – Jeddah Posted Date: Sep 19 2022 Job Purpose To release product that is manufactured and/or packaged in compliance with SFDA, QMS and cGMP requirements and to Ensuring that all operations relevant to quality within the site are undertaken following the appropriate standards Your Key Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Key Responsibilities Review Batch Record Documentation for compliance to cGMP’s, SOP's, internal and regulatory requirements. Support the release process to ensure that products released for sale have been manufactured and packaged in accordance with cGMP and applicable laws. Perform the achieving and destruction of the batch dossiers and retain sample as per relevant procedure within the lead time. Highlight any trending occurring during recording of documentation error to OQ Supervisor. Oversight the operations in all shifts, extended hours and weekends whenever is required. Ensure that all operations at site i.e. manufacturing & packaging processes, lab operations, warehouse and engineering are operating within the defined controls as per relevant BMRs, BPRs & SOPs by frequent performing the GEMBA and coaching of staff to develop their Quality mindset. Support all department at site in Quality matters whenever is needed during investigation / issues. Communicate to Production, QC, Procurement and Supplier Quality about any issue during the evaluation of packaging/raw material and during manufacturing/packing process in conjunction with manufacturing/packaging staff. Adhere to Safety, Quality and GPS standards and sustain the relevant QA & EHS KPI metrics to achieve Zero Accident, Zero Defect, Zero Waste and continues improvements. Perform Self Inspection (L1 Audit) in OQ department as per L1 Audit Schedule. Conduct and support site audit inspection preparation and participate as an audit team member in audits, including Level 1 (Self-Inspection), 2 (i.e. monitoring audits), 3 (e.g. CAG, A&A) and 4 (e.g. SFDA) audits. Handle deviation, supplier/customer complaints and OOS in coordination with area owners and ensure implementation of CAPA and closure within required timeline. Participate in all investigation of product incidents, supplier complaints and GMP deviations so as to drive for root cause identification and corrective and preventive action. Review and approve supplier deviation and product failure investigation related to suppliers and assess those investigations have been carried out satisfactorily and evaluate the impact on quality and release of the materials. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Graduate Bachelor of Science or Pharmacy A minimum of 2 years of experience in a pharmaceutical environment. Expertise in the field of quality. Good knowledge of GMP & EHS and Proven record of attention to detail. Experience of production processes, equipment and systems. Preferred Qualifications: Post graduate degree. Essential Skills and Abilities: Good level of English language written & spoken and good documentation ability. Good in Computer skills (Microsoft office). Good inspections skills & experiences. Good Technical writing skills. Problem solving skills. RCA – Root cause analysis. Why GSK? GSK is 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. GSK is 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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.