Operational Quality Manager

Cairo, Egypt

Job Description

Site Name: Egypt - Cairo
Posted Date: Jul 20 2022
Are you a Manufacturing Professional looking for a challenging opportunity to drive Quality Management System improvement and simplification for your local region while working with Quality Managers across the globe? If so, this could be a great position for you to explore. As an Operational Quality Manager/Lead, in conjunction with the Site Quality Director and Value Stream Manager, you will be responsible to evaluate future business needs (e.g. Site Business Plan and Regulatory Intelligence) and agree/design a strategy to ensure the Operational Quality Section meet these needs. You will drive change by delivering the strategy via means of culture change, new technologies, organization change and ways of working, ensure that products released for sale have been manufactured and packaged, in accordance with the licensing requirements, Good Pharmaceutical Manufacturing Practice and business requirements, and promote quality/compliance within the Product Streams, In addition, you will ensure that Products are available on time, complying with policies and standards, and exceed customer expectations. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • In line with the requirements of the Value Stream Leader provide an effective product release
    service which ensures that all products released for sale or further processing have a quality
    appropriate to their Intended use, i.e. comply with the export market, local Egyptian and
    Company GMP Standards and Product Quality Specifications.
  • Ensure Quality Incidents associated with products manufactured and packed with In the Value
    Stream are managed in line with the QMS and local procedures. Manage LIC, PIRC, Recall functions In coordination with Site Quality Head.
  • Ensure that there is effective management of investigations (including CAPA) and assessment of
    data from products failing to meet requisite standards and make batch disposition decisions on rejection or rework in consultation with the Site Quality Director , Value Stream Manager and Site Director as appropriate.
  • Influence Quality Improvement programs (QIP )and work with the appropriate Value Stream
    Manager and technical colleagues with the aim of reducing rejects and customer complaints and
    In doing so achieve a right first time/by first intent culture.
  • Handle investigations of deviations, Data integrity deviations, complaints, OOS & OOT results, in coordination with production supervisors, Labs, Warehouse and ensures implementation of appropriate CAPA & ensure investigation closure within specified time with intended Quality requirements
  • Manage the Quality and where appropriate the Technical interfaces between the Site and Auditors during Audits.
  • Sign-off the Stream Periodic Product Reviews.
  • As appropriate manage the Quality sign off/approval of all quality related systems, procedures and documentation utilized within the Value Stream and ensures compliance with and Company GMP Standards (i.e. QMS) and Product Quality Specifications.
  • Ensure that any changes raised for Value Stream manufactured and or packed products have been appropriately validated and documented using the Site systems of approval. Manage the Quality Function sign off for Stream related Change Control Requests
  • Manage an effective Quality Team aligned to Product Stream by promoting a culture of task delegation and single touch 'ways of working.
  • Be responsible for technical and personal development of direct reports by using effective appraisal and performance management and implement training for Operational Quality staff to ensure competence In performing their required function.
  • Provide GMP advice to the Value Stream on an ongoing basis, as required and promote safety awareness by all Operational Quality staff.
  • Deputize for the Cairo Quality Site Head as required and investigate counterfeit Incidents with proper escalation in coordination with Site Quality Head.
  • Ensure Annual review reports/trends are prepared, reviewed and Issues have been escalated and necessary actions have been taken ex: deviations, complaints, OOS, OOT.
  • Increase awareness of subordinate and make the most of using GPS tools for effective Information search and on-going improvement in ways of working.
  • Ensure that EHS policies and procedures are Implemented during work and that all manufacturing and packaging processes are done per GSC requirements.
  • Manage Documentation life cycle management and ensure that data integrity requirements are followed.
  • Responsible to participate in Self Inspection program within OQ department to confirm department adherence to LSOPs and policies with adequate follow-up actions.
  • Review and approve PCCE risk assessments related to each area in VS with appropriate controls to minimize potential product Quality risks.
  • Review and approve Ejects and Rejections risk assessment each machine in VS with appropriate controls to minimize potential product Quality risks and complaints.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in Pharmaceutical Sciences.
  • Minimum 7 years of experience in Operational Quality or Operations within the pharmaceutical industry.
  • Up to date knowledge of current GMP, EDA Regulatory requirements, GSK QMS System.
  • Excellent documentation and report writing skills.
  • Excellent verbal and written communication skills.
  • Familiar with IQ, OQ, PQ, facility, utilities and equipment, with solid experience in cGMP/GLP compliance activities.
  • Experienced in handling regulatory interfaces such as inspections.

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. 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.

Beware of fraud agents! do not pay money to get a job

MNCJobsGulf.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.


Related Jobs

Job Detail

  • Job Id
    JD1406752
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Cairo, Egypt
  • Education
    Not mentioned