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Operational Quality Assurance Officer

4 weeks ago

مصر, Egypt GSK Full time

**Site Name**: Egypt - Cairo

**Posted Date**: Feb 13 2024

Are you an **Operational Quality Assurance Officer **who is energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If so, this role is the one for you to explore.

As an **Operational Quality Assurance Officer**, you will be responsible for following up adherence to OQ system & GMP in production areas, Check batch-related documentation, and provide reports about quality performance against approved standards
- This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:_
- Revise Quality technical documents according to Corporate Standards, such as GQP’s, GQMP’s and FPG’s. This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials.
- Ensure proper sampling of intermediate, bulk and finished product batches for routine testing, validation practices and cleaning samples.
- Monitor calibration of production equipment and IPC testing instruments.
- Review batch related documentation for completeness, correctness and compliance to approved standards.
- Report any observed incidents during routine production and follow up its correction and corrective action.
- Ensure that GMP Standards are followed properly in the Warehouse, Dispensing and manufacturing areas and during the manufacturing and packaging processes.
- Handle deviations, complaints and OOS & OOT in coordination with area owners and ensure implementation of CAPA and closure within required timeline.
- Team member in self inspection and provide Quality inputs in CCRs.
- Support EHS & GPS implementation in managing different activities.
- Ensure identification and rejection of non-conforming materials/products according to GMP standards.
- Responsible to participate in Self Inspection programme within OQ department to confirm department adherence to LSOPs and policies.
- Ease the production process with meeting GSK quality standards
- Coaching operators to ensure that quality mindset is embedded in their day to day activities.
- Handling PCCE incidents in the VS Areas.
- Responsible for and ensure propper implementation of ALCOA+ principles
- Ensure proper handling eject and reject Activities in VS areas.

**_ Why you?_**

**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- University graduate, pharmacy or science.
- 1 -3 Years' experience in similar role.
- Knowledge of EHS and GMP requirements
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, Equipment and Strong experiences in cGMP/GLP compliance activities.
- Good command of English (spoken and written)
- Good Computer and communication skills (Word and Excel).

**Preferred Qualification**:

- Able to demonstrate experience of managing diverse teams of professional staff and effective.
Good command of English and computer skills.
- Self-motivation, empowerment and adaptation to business changes.
- Strong prioritization and organization skills.
- budgetary control against agreed targets.

**Why Us?**

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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**:
**Important notice to Employment businesses/ Agencies

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