QA-konsult Pharma (QP/RP)

Would you like to be part of a growing organization where you get a large degree of influence and work with experienced colleagues? Customers includes small and 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. At SRS, you get both the closeness to and the fellowship of your colleagues, while you are responsible for your own 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
SRS is 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 a merit.
Experience of working with pharmacovigilance and adverse reaction reporting is a merit

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 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.
For more information about the company, see www.srs.se
How to apply
Contact Director Quality Assurance Pharma, Marie Lindholm for more information about the position: marie@srs.se or 070-090 81 00
Apply to jobb@srs.se