Job Opportunities at StreSERT Services Limited

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• Contents


• Open Jobs
  
  
  
  1. Regulatory Affairs Specialist (Sub Saharan Africa)
  
  
  2. In-Process Checker
  
  
  
  


• 
  Method of Application
  

Regulatory Affairs Specialist (Sub Saharan Africa)

• Job Type Contract , Full Time


• Qualification BA/BSc/HND


• Experience 4 – 5 years


• Location Lagos


• Job Field Pharmaceutical&nbsp

Our client is a multinational Pharmaceutical organization. They seek the services of a Regulatory Affairs Specialist for a 2 years contract engagement.

Department: RA (Global Drugs Development) GDD

Reports to:  RA Head

 – 2 YEARS CONTRACT

Job Purpose

• Support the region (Sub Saharan Africa – SSA) with lifecycle maintenance activities


• Coordinate submission of post-approval changes including variations and renewals for the region (SSA)


• Coordinate update of (Chemistry Manufacturing & Controls – CMC) database when there are changes in country regulations and/or requirements


• Maintain all necessary databases (e.g. DRAGON) to ensure regulatory compliance at all time.


• Maintain open communication with the different stakeholders and regularly provide information when required.

Major Accountabilities

• Ensure the RA CMC database for the different countries in the region is up to date


• Evaluate post-approval changes for impact on product supply and communicate to stakeholders accordingly


• Ensure submission of post-approval changes such as production transfers, MAT and pack size extension are done on-time and approvals received early enough to ensure smooth implementation


• Ensure that submissions for license renewal are done in good time before license expiry so as to achieve early approval


• Support the update local/Regional Working Practices or SOPs when required.


• Ensure adherence to Global and local/regional processes.


• Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary


• Ensure compliance to global and local KPIs.


• Develop and maintain good working relationships with other company functions/departments both locally and globally, as well as with health authorities as required

Key Performance Indicators

• Ensure compliance with relevant Health Authority guidelines and regulations


• Ensure all post-approval changes are submitted on time and follow up for approval


• Meet product re-registration due dates and escalate possible adverse impact due to loss of license accordingly


• Accurate maintenance of relevant regulatory information management system


• Achieve Regulatory compliance deliverables as per global targets


• Address issues related to compliance with urgency with escalations as appropriate


• Share emerging regulatory intelligence with RA Heads

ROLE PROFILE

Education:          B. Pharm             

Languages:         Fluent in English (mandatory)

Experience:        At least 4-5 years RA experience

• Good communication and negotiation skills


• Good knowledge of CTD dossier format


• Detail-oriented and organized


• Good inter-personal skills

Application:

Candidates with a similar background who do not hold permanent employment should forward CVs to ‘recruitment@stresertservices.com’ using ‘RAS-2YR’ as the subject of mail before 1st March, 2020. Applicants without the aforementioned background and experience need not apply.

go to method of application »

In-Process Checker

• Job Type Full Time


• Qualification BA/BSc/HND


• Experience 1 year


• Location Lagos , Ogun


• Job Field Manufacturing&nbsp

Location: Ikorodu, Lagos State & Ota, Ogun State

JOB SUMMARY

As an In-Process Checker, you are responsible to monitor all areas of production inspection process, including in-process Quality Assurance, incoming raw materials, and expiration dates. Review batch records of additives for accuracy and completeness for product disposition.

RESPONSIBILITIES  

• Issuance of Line Clearance


• Monitoring GMP compliance


• Filling of production logbook


• Sampling of products and raw materials


• Carrying out various quality test in the lab


• Monitoring production process and compliance


• All other instruction given by the line manager and other superiors

JOB QUALIFICTIONS/REQUIREMENTS 

• At least 1 year of experience directly related to the duties and responsibilities specified.


• Bsc/HND in Natural Sciences Computer literate

Salary

Net Pay – N50, 000

Application Closing Date

28th February, 2020.

How to Apply

Applicants who meet the requirements listed above should forward CVs to ‘outsourcing@stresert.com’ using “IPQA” as subject of the mail.

Method of Application

Use the emails(s) below to apply

• Regulatory Affairs Specialist (Sub Saharan Africa) – recruitment@stresertservices.com


• In-Process Checker – outsourcing@stresert.com

 

source: https://jobcenternigeria.com/job-opportunities-at-stresert-services-limited/