1. Management of Qualification / Validation of Jamjoom Pharma Ensure timely completion of all Process Validations, Facility / Area Qualifications, System Validations, Equipment / Machine Qualifications & Cleaning Validations
2. Management of VMP / VRB of the site Lead to Execute VMP (validation Master plan) and run the activities through VRB (Validation Review Board)
3. Technical Documentation Management Ensure timely review & approval of all technical documents like Protocols, log guides, specifications, product stability data & Quality agreements with external parties
4. Management of Change Control System Ensure timely implementation of all Changes with respect to Facility, Processes, Systems, Documentations
5. Management of Exhibit / Stability batches Ensure timely approvals for process documentations related to Exhibit batch manufacturing of new products
6. Management of Item Master related to Quality modules in SAP ERP System Ensure timely creation of all requested item codes for different materials, products & commodities after review & approvals to allow their usage for business demands
7. Management of Non-conformances Ensure timely decisions & dispositions of all non-conformances related to Raw Materials, Intermediate & Finished Products
8. Management of Vendor Approval System at Site Ensure timely approvals & dispositions for Vendors related to Raw / Packaging materials & Miscellaneous items at site. Furthermore, ensure monthly status are published for Approved Vendors to relevant stakeholders.
9. Technical supports to Regulatory Ensure to provide all required Regulatory support including timely submission of Process Validation protocols of new products for registration purpose & providing technical support in addressing Regulatory queries whenever required. Ensure to provide all required documentation to regulatory.
10. Technical Support for New Projects / Business development Ensure timely review of technical layouts / drawings for new projects & technical files of new business partners Job Skills Required
Strong communication skills both written & verbal
Strong Management / leadership skills
Soft skills for handling people
Knowledge & understanding of Quality & Regulatory guidelines / procedures
Computer literate
Able to work in competitive environment
Education & Certification
Minimum Master’s degree Science (Pharmacy / Chemistry / Microbiology) Additional management courses like skills in supervision & other relevant certifications are required Knowledge & Experience
Sound knowledge of GMP guidelines (local / international) & minimum 20 years of experience
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