Operational Quality Manager & Site Data Integrity Lead



Quality Assurance
Jeddah Saudi Arabia
Posted on Thursday, May 30, 2024

As an Operational Quality and Site Data Integrity Lead, you will be supervising the Operational Quality activities such as batch release, OQ oversight of production & testing related activities and GMP investigation to ensure compliance with SFDA guidelines, relevant local standard operating procedures, QMS requirements and prevalent cGMP standards.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

Key responsibilities:

  • Responsible for review of all completed Batch Dossier record of each product manufactured / packed by Glaxo Saudi Arabia Ltd. prior to the release of the products to market.

  • Supervision of the QA random in-process checks at various stages of the manufacturing and packaging as and when required.

  • Involved in the Investigation of GMP deviations for handling and maintaining the record of investigation of the GMP deviations.

  • Involved in the investigations of the product complaints related to GSAL site to ensure all complaints are recorded, investigated and reviewed properly.

  • Responsible for preparing / revising SOPs of OQ department to align with SFDA guidelines, QMS requirements and cGMP practices.

  • Responsible for Supplier Deviation handling, investigation and ensuring those CAPAs are tracked and closed in timely manner.

  • Responsible for provide Data for Zero Defect on weekly and monthly basis.

  • Responsible to review and compliance check of BMRs, BPRs, of all products pertaining to the production.

  • Support Production, Logistics, Engineering, QC & technical in quality matter to ensure that all the processes are operating within defined control as per relevant documents (BMIR BPR & SOPs)

  • Involve in problem solving to resolve the quality issues quickly to support Zero waste.

  • Responsible for maintaining the electronic record and hard copies for Site Deviation, Supplier Deviation and Customer Complaint.

  • Involved in raising ZAPs and initiatives to ensure EHS standard are maintained in OQ department.

  • Perform L1 Audit of OQ department as per Departmental Audit Universe and supervise the completion of CAPAs on time.

  • Supervise the OQ governance in shift, extended hours and holidays and or whenever is required.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor of Pharmacy / Master of Chemistry from a recognized institution.

  • At least Five (05) Years experience in a pharmaceutical environment and minimum 2 years in supervisory role.

  • Expertise in the field of quality.

  • Excellent knowledge of GMP & EHS.

  • Excellent level of English language. [Written & Spoken]

  • Experience of production processes, equipment and systems.

  • Good documentation ability.

  • Competency level – Competent.

  • Good in Computer skills (Microsoft office )

Business challenges:

  • Medium job complexity, gaining of medium range of experience & technical expertise required. Knowledge of GSK QMS policies & processes (as applicable).

  • Interaction with all departments (except Finance) within the factory on a regular basis (e.g. Audits, CAPA follow up, etc).

  • Low level of freedom to make decision and to act decisions is made in conjunction with Operational Quality Supervisor.

  • High level of influencing required and knowledge pharmaceutical manufacture to back up this behavior. Ability to build effective working relationships with departments is an important requirement in order to fulfil the goals/requirements of this position.

  • Accountable for individually identified risks and escalate to the Operational Quality Supervisor.

Personal challenges:

Develop good relationship with factory staff. This will maximize overall team effort and therefore raise customer satisfaction.

Co-ordinate with Production & QC as & when required to ensure right information is shared.

Post Closure Date: 8. June.2024

Why GSK?

Uniting science, technology and talent to get ahead of disease 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

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.