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    Talent Acquisition Coordinator - Cairo, مصر - Concentrix Egypt

    Concentrix Egypt
    Concentrix Egypt Cairo, مصر

    منذ 5 أيام

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    وصف

    About PSC Biotech

    Who we are?
    PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

    Take your Career to a new Level
    PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

    Employee Value Proposition
    Employees are the heartbeat of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

    Responsibilities:

    With energy and enthusiasm, the Quality Ops Specialist will:

    Support quality aspects of drug substance manufacturing to ensure compliance with company policies, procedures and regulatory expectations.

    Provide Quality oversight to Upstream manufacturing activities on the production floor as part of facility start up and routine manufacturing.

    Review and approval of site operations Standard Operating Procedures (SOPs) and Work Instructions (WI).

    Support electronic batch record review and review of related batch documentation to ensure timely release and disposition of drug substance batches. Review will encompass review of production and equipment logbooks and audit trails.

    Support sustaining activities such as Deviation and Change Management.

    Serve as a quality resource for assessing Quality Risk Assessments

    Use of Quality Risk Management and Operational Excellence to promote continuous improvement.

    Provide quality oversight for engineering changes impacting manufacturing equipment.



    Requirements

    Qualifications:

    General

    • This role requires a minimum of 3 years experience in, Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
    • A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
    • This role will be a 12/4 shift role. 4 consecutive 12 hr shifts followed by 4 days off rolling.

    Technical

    • Experience working in regulated environment with exposure in the Regulations & guidance s GMP, CGMP, GAMP, 21 CFR Part 11
    • Experience in batch record review and review of batch related documentation.
    • Technical experience in aseptic processing or manufacturing operations.

    People

    • The motivation to be an inspiring member of a high performing team.
    • The desire to continuously learn, improve and develop
    • A great communicator, decisive decision maker and proven ability to deliver excellence
    • Confidence to direct off-site suppliers to the project, willingness to support the team and a laser light focus to deliver excellence
    • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
    • Experience with new product introductions and/or process qualification/technology transfer
    • Detail oriented and meticulous worker

    Education:

    • Bachelor s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career.

    #LI-SO1



    Qualifications: General This role requires a minimum of 3 years experience in, Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry. A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends. This role will be a 12/4 shift role. 4 consecutive 12 hr shifts followed by 4 days off rolling. Technical Experience working in regulated environment with exposure in the Regulations & guidance s GMP, CGMP, GAMP, 21 CFR Part 11 Experience in batch record review and review of batch related documentation. Technical experience in aseptic processing or manufacturing operations. People The motivation to be an inspiring member of a high performing team. The desire to continuously learn, improve and develop A great communicator, decisive decision maker and proven ability to deliver excellence Confidence to direct off-site suppliers to the project, willingness to support the team and a laser light focus to deliver excellence Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends. Experience with new product introductions and/or process qualification/technology transfer Detail oriented and meticulous worker Education: Bachelor s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career. #LI-SO1
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