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Job Category
Pharmaceutical
Job Description
- Should be able to demonstrate strong understanding of USFDA/ MHRA/ EU or local guidelines.
- Responsible for setting strategy direction for the entire Quality Control & Microbiology Department and team.
- Conducts performance reviews for teams
- Development, review, revise and implementation of Standard Operating Procedures (SOPs)/ Standard Test Procedures (STP’s), validation protocols for as and when required.
- Responsible for review and approval of method and product transfer documents/ reports to ensure compliance with all cGMP and all regulatory requirements.
- Track compliance issues within all departments and ensure completion within defined timelines.
- Timely release of finished products (sterility testing), incoming materials (Bacterial Endotoxin Testing, Bioburden) as and where necessary
- Timely review and approvals of laboratory investigations, change controls and corrective and preventative action (CAPA), providing manufacturing support, record review/approval, and ongoing projects support (if any).
- Manage and evaluate (trending) deviations, OOS/ OOT, Corrective Actions and Preventative Actions (CAPAs).
Support team by guidance and coaching and provide direction/approval of activities and decisions. - Share oversight to individuals and team on personal development, performance, and quality related issues. Write and deliver performance reviews.
- Ensure proper use of assets, budget, and personnel and communicate effectively with key customers and partners, both within the site and outside as appropriate
- To monitor the sample management system and planning of testing of raw material, in process samples packing material and finish product.
- To ensure the cGMP norms are followed while performing analysis.
- Lead projects that impact the Quality Management System.
- Report on progress against schedules, milestones and project goals, evaluate project resource needs and availability, identify and report gaps or project constraints, and develop solutions for successful implementation.
Skills
- Ability to manage handled a team of 10 to 35 colleagues.
- Familiarity with EMEA/MHRA; SFDA; USFDA
- Minitab or other Statistical Software (SPSS)
- SAP is a plus
Education
Chemistry
About The Business
KSPICO we are Kuwait’s only pharmaceutical manufacturing company.
The products we manufacture are sold in Kuwait, distributed to most of the Middle East, and reach customers world-wide.
KSPICO is part of Mezzan Holding Co. one of the leading food, healthcare, and consumer conglomerates in the Middle East with a celebrated heritage of over 75 years.
Headquartered in Kuwait with direct operational activities in Kuwait, UAE, Qatar, Saudi Arabia, Iraq and Jordan
Mezzan Holding Co
- Employs 8,500 people (50+ nationalities)
- Distributes over 34,000 Stock Keeping Units (SKU)
- Serves over 100,000 meals a day in Kuwait, Qatar and the UAE through its catering business
- Has a total of 130,000 square meters in food, beverage and FMCG manufacturing facilities in Kuwait, Qatar, UAE.
- Represents some of the biggest names in the FMCG and healthcare industries.