Shelys Pharmaceuticals Ltd Jobs

Positions advertised are,
1. Executive- Quality Assurance (Documentation)- (2)
2. Executive - Quality Assurance (Validation) - (1)
3. Executive - Regulatory Affairs - (1)

Shelys Pharmaceuticals Ltd, a member of the Aspen Group of Companies, is a leading pharmaceutical manufacturing company in East Africa. We are seeking to recruit qualified & experienced individuals for the below positions.

Executive- Quality Assurance (Documentation)- (2)
Desired Profile
Education: Bachelor of Pharmacy
Experience: 0 - 4 years
Good knowledge of Microsoft office and databases

Reporting Line
To Head - Quality Assurance

Duties & responsibilities
Accountable for overall documentation
Active involvement for implementation of Quality Management System
Implementation of Good documentation Practices
Preparation, compilation and review of annual product Quality review
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Executive - Quality Assurance (Validation) - (1)
Desired Profile
Education: Bachelor of Pharmacy
Experience: O - 4 years
Good knowledge of Microsoft office and databases

Reporting Line
To Head - Quality Assurance

Duties & responsibilities
Accountable for overall validation activity
Preparation and review of site master file and validation master plan
Preparation of cleaning validation protocols and reports
Preparation of HVAC qualification I validation protocols and reports
Designing the hold time study protocols and executing for the products
Preparation of DQ, IQ, OQ and PQ for manufacturing equipments
Review and monitoring of validation of process and qualification of equipment/instrument
Review of instrument and equipment calibration
Preparation of temperature mapping protocols and reports
Any other responsibilities given by the Head of the Department I Management
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Executive - Regulatory Affairs - (1)
Desired Profile
Education: Bachelor of Pharmacy
Experience: 0 - 4 years
Good knowledge of Microsoft office and databases

Reporting Line
To Head - Quality Assurance

Duties & responsibilities
Preparation of product registration dossiers for Tanzania and various other countries as per registration guidelines
Review of queries from regulatory agencies and ensure timely response to it
Timely submissions of Amendments/Variations/annual updates, Technical Data Package/Open Parts of DMFs responses to regulatory agencies
To maintain regulatory database, registrations and compliance to procedures
Sound knowledge on WHO, ICH, TFDA and other regulatory guidelines
Responsible for checking of artworks as per the guidelines
Preparation of technical file for tenders (Product Permission, CPPs, FSCs, Product License and other relates documents) as per business plan
Any other responsibilities given by the He.ad of the Department I Management.
Interested candidates have to send their application letters, updated CV (including three referees), copies of academic certificates and daytime telephone contact to the undersigned through the address and or email below.
The Senior Human Resources Manager
Shelys Pharmaceuticals Ltd
Nwe Bagamoyo Rd, Mwenge,
P. O. Box 32781
Dar es Salaam