Senior Manager Qa/ Validation (copy)
Jeddah, Saudi Arabia
Job Description
Key Accountabilities & Activities
S.#
Key Accountabilities
Key Activities
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
Education & Certification
Key Accountabilities
Key Activities
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
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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Job Detail
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Job IdJD1407658
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationJeddah, Saudi Arabia
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EducationNot mentioned