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QA consultant

 

Would you like to be part of a growing organization where you get a large degree of influence and work with experienced colleagues? 


We work with small to medium-sized companies who need the support of senior expertise in a variety of areas, as well as larger companies that need additional support in their 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. SRS 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 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 our team of 6 people 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 of import of pharmaceuticals from third countries, in particular IMP's, is preferred.

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


As a person, 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.
 

Location
Preferably in Stockholm/Uppsala/Mälardalen, but there is flexibility for working remotely. However, regular onsite meetings will be held at the office in Danderyd/Stockholm.
Travelling may occur to some extent.


Corporate culture and conditions
Personal sustainability and balance in life are important to the company. Part-time work can therefore be considered.


SRS is a small and personal company; 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 an extra pair of hands but a competent addition to the client's organization. 
The position is a full-time permanent position with a fixed monthly salary. Start date according to agreement. 


About SRS
With Scandinavian Regulatory Services' team of experts and through our network of selected partners, we specialize in providing expert support for market access through quality management and regulatory affairs, as well as compliance activities in the post-approval phase.
Founded in 1992, SRS offers expert and experienced consultants serving regulatory issues, quality assurance, product development, in the areas of medical devices, IVD, pharmaceuticals, drug combinations, and cosmetics. 

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

Regulatorisk och kvalitets (RA/QA) konsult, Medicinteknik


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

Du kommer arbeta med dina egna projekt med rådgivning om regulatoriska och kvalitetskrav inom det medicintekniska området, framtagande av regulatoriska strategier, underhåll av registreringar, sammanställning av tekniska filer, 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. 


Hör av dig till Medicinteknisk chef Karin Rye 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.