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QA & RA Manager

EQL Pharma AB

07 nov

Lund
Sweden

PharmaRelations is the Nordic market leader within talent services for the life science industry, with over 270 colleagues and with offices in Sweden, Norway, Denmark and Finland. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Our head quarter is located in Solna, Sweden.

We are again partnering with a EQL Pharma – an entrepreneurial pharmaceutical company focusing on simplicity and efficiency to be able to deliver cost-efficient medicines of highest quality to pharmacies and hospitals, primarily in the Nordic region. The company is growing in a rapid speed, and we are looking for their next star, i.e., a Quality Assurance & Regulatory Affairs Manager, to join their internal team in Lund.

The company conducts extensive development activities in collaboration with partners in Asia, Europe and India. The strategy is to develop generic medicines in areas where the competition is limited, so-called niche generics. The focus is not on specific therapeutic areas, but rather on the opportunities that can be identified in the Nordic market for prescription medicines sold in pharmacies or used in hospitals.

The entire business is based on EQL Pharma delivering the cheapest medicines to pharmacies and hospitals, in this way daily lowering the cost of high-quality drugs for patients and society.

QA Manager (approx. 50 %)

·        Support in maintaining and updating the QMS (SOPs, Quality Manual, Site Master File etc.)

·        Support in qualification and audits of EQL Pharma´s Suppliers

·        Perform Risk Assessments of Suppliers and ensuring that there is an updated Audit Plan in place

·        Establish and maintenance of Technical Agreements/Quality Agreements with relevant Suppliers

·        Supporting regular Management Reviews and ensuring that quality KPIs and trends are continuously reported to the Management Team

·        Coordinate and support Analytical Method Transfers

·        Documentation, assessment and investigation of deviations

·        Implementation and follow up of CAPAs

·        Ensuring that Annual Product Quality Reviews are received for EQL Pharma´s Products and that the CMO´s parts are evaluated from the MAH´s perspective

·        Participate in internal and external audits and authority GMP and GDP inspections

·        Support Product Complaints related evaluations as necessary

RA – Life Cycle Management (approx. 50 %)

•      Creation of variation and renewal applications to competent authorities in the Nordics and other European countries

•      Direct contact with competent authorities, responsible for compiling high quality replies to authorities ‘questions

•      Submission of variation and renewal applications through the national procedure and DCP/MRP

•      Publishing in eCTD

•      Assess change control cases from CMOs and decide on impact on dossier/required actions

•      Responsible for product information (create/update SmPC/PILs, translations) and artworks for EQL Pharma´s products in the Nordic countries

•      Coordinate and act as contact person in outlicencing projects (coordinating due diligence from other parties, responding to questions, participating in cross functional meetings)

•      Contribute to creation and improvement of internal RA processes and working instructions

Qualifications

·        Minimum 3 years’ experience of GDP and/or GMP

·        At least 3 years experience of RA – including experience of classification and compilation of variation application packages and renewals (not only submission of “complete” package prepared by head office)

·        Experience in eCTD is a big advantage

·        Degree within pharmacy or equivalent education within life science

·        Strong personal drive, ability to take own decisions and ownership of tasks is necessary

·        The right candidate has a flexible and prestigeless personality

·        Person must appreciate working in a rapidly growing company with quick decisions and many tasks going on in parallel

·        The work contains a lot of interactions with different cultures, especially with India

·        Fluent in Swedish and English

What we offer

·        Hybrid working – possibility to work 2 days/week from home if wanted

·        Very nice location with own offices in the city of Lund

·        Great, ambitious team with close cooperation that have fun at work

·        Competitive benefit package (5000 kr/year in friskvårdsbidrag, company pays commuting costs)

·        Great possibilities for the right candidate for personal development, to influence decisions and build new processes

·        Possibility for the right candidate to take the role as Responsible Person GDP in the future

Why?

EQL is a small, flexible and dynamically company with short decision-making paths that offers a wide range of areas of responsibility and where over time you also become broad in your role and a lot of accountability. There is a very good atmosphere at the company where the level of ambition is high within the expert teams, where good collaborations prevail and where the learning curve is said to be high. The company faces a bright future and has a good business plan where in the long term the company will grow on a large scale by an average of 40%/year.

Do not miss this chance to take part in an exciting growth journey and to contribute to the development of cost-efficient pharmaceuticals for the Nordic markets.

How?

For further information, do reach out to Kristina Edholm (Sr Recruitment Manager) or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.

At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

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