Job Opportunities at StreSERT Services Limited
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- Regulatory Affairs Specialist (Sub Saharan Africa)
- 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
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
- 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.
- 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
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
Candidates with a similar background who do not hold permanent employment should forward CVs to ‘[email protected]’ 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 »
- Job Type Full Time
- Qualification BA/BSc/HND
- Experience 1 year
- Location Lagos , Ogun
- Job Field Manufacturing
Location: Ikorodu, Lagos State & Ota, Ogun State
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.
- 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
- At least 1 year of experience directly related to the duties and responsibilities specified.
- Bsc/HND in Natural Sciences Computer literate
Net Pay – N50, 000
Application Closing Date
28th February, 2020.
How to Apply
Applicants who meet the requirements listed above should forward CVs to ‘[email protected]’ using “IPQA” as subject of the mail.
Method of Application
Use the emails(s) below to apply