Commissioning and Qualification Lead

5 months ago


السادس من أكتوبر, Egypt AstraZeneca Full time

Working with site local team to create the Front-End Study “FES” for the Expansion Project.
- Work with Global Engineering and Global Engineering Procurement to RFP, chose & award third parties “Engineering Consultant”
- Work closely with chosen third party to deliver Concept, Basic and Detailed Design.
- Make sure designs are align with Egyptian regulation and are reviewed and approved by AstraZeneca GERE SMEs.
- Participate in Value Engineering to ensure designs are robust and cost efficient.
- Managing a team of Work Package Owners “WPOs” which is a team provided by a third party to manage process equipment technical negotiations with machine vendors along with AZ process SMEs.
- Working with GERE and Global Engineering Procurement to RFP process equipment vendors.
- Manage to WPOs team to align the process equipment technical design with the facility design.
- Reviewing tender packages issued by Engineering consultant.
- Leading technical evaluation sessions required for construction contractor awarding.
- Hiring the local C&Q team according to the required capabilities.
- Make sure the appropriate onboarding and trainings are provided to the newly joined team.
- Make sure proper project induction is provided to the team.
- Provide C&Q strategy and make sure each team member have clear objectives that aligns with it.
- Provide coaching and support to the team.
- Make sure that project team acquired building license and permits prior the construction work starts
- Review the detailed constructability plan along with GERE SMEs and Safety construction manager.
- Work closely with the consultants site supervision team to make sure construction works adheres to schedule and in compliance with AZ SHE & GMP standards.
- Make sure the detailed design “shop drawings, equipment submittals and material submittals” are reviewed and approved by the relevant GERE SME.
- Integrate the WPOs and the local C&Q team to create the detailed commissioning and qualification plan and the relevant protocols, such as URS, DQ, IQ, & OQ
- Have the C&Q local team along with the local Validation team to execute FAT, SAT, IQ, OQ & PQ and generate the relevant reports.
- Having the C&Q team to create relevant site BAU documentation for the new extension such as maintenance Records and plans, also updating CI, calibration/qualification plans list and IT register.
- Assignment of Quality and Safety CAPA activities within the project team.
- Ensure all work is executed in line with health and safety and quality system requirements
- Develop the skill set and training plans (SHE and Quality) of the C&Q team.

**Essentials**:

- Academic / Professional qualification: Bachelor degree in Engineering
- Working experience: minimum 12-15 years experience in Pharmaceutical Industry.


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