Site Name: Saudi Arabia - Jeddah
Posted Date: May 23 2022
Job Purpose
Develops and implements programs to establish and maintain quality standards
of existing products, and
internal systems and processes. Develops policies, procedures and methods to
check product, material,
components and/or operational quality and improve same.
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 …
* Overall responsibility for effective operation and Performance of QC Laboratories
* Implement and maintain effective administrative and technical procedures to ensure the QC service are aligned with cGMP and cGLP.
* Ensure that the product, materials and manufacturing environment are tested and comply with GSK and local regulatory requirements. In conjunction with QC compliance, develop, implement and monitor laboratory procedures and ensure the lab procedures and analytical methods (SOP/ BAR/ RMA/ BPS) is up to date and aligned with the last version of the regulatory guideline (GCC, SFDA & ICH), QMS, CAPs and pharmacopoeia, and ensuring compliance of laboratory activities with local SOPs.
* Maintaining all quality system related to the lab, example OOS, Audit, Quality alert, Deviation, QMS, Risk.
* Act as a contact person for any technical or compliance issue / communication related to QC laboratories and regulatory requirement for stability and product methods and specification.
* Ensure self-inspection (L1) audits are effectively performed with effective CAPAs to prevent reoccurrences. To participate in L2, L3 and L4 audits and ensure effective CAPA is applied and to ensure the closure within due date of CAPAs.
* Issuing / Ensuring the Cleaning validation / Stability studies / Maintenance / Calibration schedule are in place in beginning of the year ensure trending of critical product parameters are trended, reviewed and available for PPR.
* Ensuring laboratory CAPEX is adequately planned for and executed.
* Improve the technical capabilities of QC staff, ensuring all job competencies are identified, documented and all training needs for all QC staff are defined in their training curricula.
* Promote safe-working environment that comply with GSK EHS requirements.
* Attend all meeting related to QC labs e.g. morning production meeting, quality council meeting and provide QC Related inputs to the meetings.
* 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
* Sample management, including retain and stability samples as required
* Accountable for managing Qualification, calibration and maintenance of laboratory instruments and equipment in coordination with Validation department
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our
goals:
* Bachelor 's degree of Chemistry or Microbiology or pharmacy.
* Min of 5 Years' and up to 10 years of experience.
Preferred Qualifications:
* Bachelor or Master of Pharmacy
Essential Skills and Abilities:
* Good knowledge in quality systems and their use (Change
* control, Testing and Analysis, OOS handling, Deviation
* handling, Audits etc).
* Good communication Skills
* Computer Skills (Word, Excel & Power point)
* Fair knowledge of EHS, GMP and GLP
* Ensure all QC test performed within agreed lead time and materials release to production/ market on time, with related KPIs.
* Accountable for identifying risks and maintain the QC risk register.
* Ability to effectively prioritize required. Good people skills and communication.
* Ability to motivate staff
* Effective management of relationship with other departments essential to ensure role is effectively fulfilled.
* Good analytical and problem-solving skills required.
Why GSK?
At GSK, we have already delivered unprecedented change over the past four
years, improving R &D, becoming a leader in Consumer Health, strengthening our
leadership, and transforming our commercial execution. Now, we're making the
biggest changes we've made to our business in over 20 years. We 're on track
to separate and create two new companies in 2022: New GSK with a leading
portfolio of vaccines and specialty medicines as well as R&D based on immune
system and genetics science; and a new world-leading consumer healthcare
company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science,
talent, and technology to get ahead of disease together - all with the clear
ambition of delivering human health impact; stronger and more sustainable
shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all
this is through our people and our culture. A culture that is ambitious for
patients - so we deliver what matters better and faster; accountable for
impact - with clear ownership of goals and support to succeed; and where
we do the right thing. So, if you 're ready to improve the lives of
billions, join us at this exciting moment in our journey. Join our challenge
to get Ahead Together.
Contact information:
You may apply for this position online by selecting the Apply now button.
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