JOB VACANCY AT SHELYS PHARMACEUTICALS LIMITED TANZANIA: POSITION TITLED FOR EXECUTIVES.

Careers at Shelys Pharmaceuticals Limited, February 2018

VACANCY ANNOUNCEMENT SHELYS TANZANIA

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
==========

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
=========

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 or info@tz.betashelys.com
Important Note: Women and persons with disability are particularly encouraged to apply.

Applications to reach us on or before 28.02.2018; Only shortlisted candidates will be contacted .

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