Arbeta på Scandinavian Regulatory Services

Vi har alltid behov av att stärka upp vårt team av duktiga konsulter,

 du är välkommen med en ansökan till jobb@srs.se

 Just nu behöver vi utöka vårt team

Regulatorisk och kvalitets (RA/QA) konsult, Medicinteknik och IVD

Ort: Stockholm/ Hela Sverige

Vi söker dig som vill arbeta inom SRS konsultverksamhet med medicinteknik och IVD. Arbetet innebär att stödja kunder med regulatoriskt och kvalitetsarbete såsom bygga eller utveckla kvalitetssystem, produktutveckling, CE märkning för Europa samt registrering i övriga länder.

Du kommer arbeta både i egna projekt och i team, med tex rådgivning gällande regulatoriska och kvalitetskrav inom det medicintekniska området samt produktutveckling, framtagande av regulatoriska strategier, sammanställning av tekniska filer, underhåll av registreringar,  införa eller utveckla kvalitetsledningssystem mm.

Arbetet kommer att innefatta utöver kontakt med kunder även kommunikation med anmälda organ, myndigheter och andra samarbetspartners.


Du har relevant högskoleutbildning, flerårig erfarenhet av medicintekniska regelverket, både inom RA och QA. Arbetet kräver att du tycker om att arbeta självständigt och i nära samarbete med kunder. Du har ett flexibelt arbetssätt och kan se både till helhet och detaljer, och finner inspiration i att ta fram lösningar som uppfyller regelverket för våra kunders räkning. 

För mer information, besök Move Ups hemsida.

 

Du kan också höra av dig till Karin Rye, chef för medicinteknik gruppen om du vill veta mer om tjänsten eller hur det är att arbeta som konsult: rye@srs.se eller 076-669 77 11.

 

Vi kommer att granska ansökningar i den takt de kommer in, ansökningar skickas till jobb@srs.se eller via Move Ups hemsida

 

Grow with us! Work with experienced colleagues, get a large degree of influence, responsibility and get the flexibility you want in a job. 


Join our team and become our new QA consultant!

SRS (Scandinavian Regulatory Services ) is a Swedish consultancy firm in Danderyd, Stockholm, that offers regulatory and quality expertise and services to the pharmaceutical, medical device, cosmetic and associated industries.
We work with small to medium-sized companies that need the support of senior expertise in a variety of areas, as well as larger companies that need additional support in their organization. 

We are a small company and people are our most important asset; our ambition is to be as important to the customer as the customer is to us. A consultant from SRS should not primarily be a pair of extra hands but a competent addition to the client's organization. 
At SRS, you get both the closeness to and the fellowship of your colleagues, while you are responsible for your assignments with our customers. 

We are a growing company with senior-level employees and a large international network of specialized consultants/consulting services in various fields and countries.

 

Quality Consultant, Pharma

Scandinavian Regulatory Services is looking for an experienced quality consultant in the pharmaceutical field.

You will be part of a team of 6 professional, experienced and helpful colleagues, responsible for supporting customers in their quality work according to EU GMP/GDP. Our customers range from start-ups to large companies; hence work can include anything from building a company's quality system from start to compliance work in the customer's established systems.

 

Responsibilities

Management of assignments in the field of pharmaceutical Quality, such as:

·     Set up and maintenance of GMP/GDP quality systems

·     GMP/GDP compliance

·     Support customers in the roles of QA, QP and/or RP

·     Internal audits

·     Vendor audits and assessments

·     Support customers during audits and inspections

·     Training

·     Regular quality-related tasks such as complaint handling, change management and SOP maintenance

 

Experience

·     At least 10 years of experience in quality assurance within pharma distribution and/or production

·     Experience of working as an expert (QP or RP)

·     Academic education that meets the requirements to be approved as QP or RP by the Medical Products Agency (LVFS2004:7)

·     Experience in communication with authorities

·     Professional level of Swedish (spoken and written) is a requirement

·     Professional level of English (spoken and written) is a requirement

·     Experience in working with pharmacovigilance and adverse reaction reporting is a preferred qualification.

Qualities we look for in our new colleague:

You are driven, thorough, self-motivated, and used to working towards set timelines. You have a flexible way of working and can see the whole picture as well as the details. You may be assigned as the sole QA person in the customer's organization, it is, therefore, important that you are a structured person who communicates well and is comfortable in making decisions.

Although, whenever needed our team will support each other to interpret requirements or to help find the best solution for our customers, and you are open to ask for support or share knowledge and experience.  

 

Full Time or part-time

The position is a full-time permanent position with a fixed monthly salary. 

Start date according to agreement. 

It is very important to us that our team members find a balance between work and their personal life, so part-time work can therefore be considered.

 

How to apply

Contact Director Quality Assurance Pharma, Marie Lindholm for more information about the position: marie@srs.se or 070-090 81 00

 

We will review applications at the rate they come in, Please send your application to jobb@srs.se 

 

Click here to read more about SRS