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Quality Manager & Responsible Person

Glenmark Pharmaceuticals

09 feb

Rekrytering, Pharma
On behalf of our customer Glenmark Pharmaceuticals, Nordic, we are looking for a Quality Manager & Responsible Person. This position is based in Malmö.

THE COMPANY

Glenmark Pharmaceuticals Ltd. is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. The Company focuses on the key therapeutic areas of respiratory, dermatology and oncology and has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries.

Glenmark is ranked among the world’s top 100 biopharmaceutical and among the world’s top 50 companies in the off-patent sector. The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world’s most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year.

The Nordic subsidiary Glenmark Pharmaceuticals Nordic AB (GPNAB) is based in Malmö, in Southern Sweden. The Company´s high-quality generic pharmaceuticals are sold in all five Nordic markets, i.e. Sweden, Denmark, Norway, Finland, and Iceland.

Since its inception in 2017, the Nordic business has grown rapidly and the Nordic portfolio includes many indication groups, focusing on the therapy areas of central nervous system, cardiovascular system and respiratory system.

Today, the Nordic team consists of 10 dedicated members from various Nordic geographies whereof 7 employed and 3 full time consultants.

THE ROLE

RESPONSIBILITIES

Role overview

Responsible for ensuring compliance across the Nordic countries to EU Good Distribution Practices and Quality Assurance requirements. Acting as the key interface between the regional Quality functions and the local business, ensuring appropriate communication with the Country Manager and other departments such as Pharmacovigilance, Commercial, legal and Medical Information.

The RP position falls within the Distribution QA function of the QA Europe group, whose primary accountability is to ensure that all products on European (EEA) market have been released, stored and distributed in compliance with EU Guideline 2013/C343/01. Specifically, the position is responsible for:

  • Monitoring the contract warehousing and transportation for the 5 Nordics markets (Sweden, Denmark, Norway, Finland and Iceland) and ensure that the quality, safety and efficacy of products is safeguarded during storage and distribution.
  • Controlling quarantine, recalls, on hold, falsified medicines and returns from the Nordic markets to ensure that they do not enter distribution.
  • Acting as the customer-facing interface for complaints, complaint samples and complaint close-out letters.
  • Delivering of Good Distribution Practice (GDP) training internally and to contractors.
  • Performing audits on the distribution chain in Europe on behalf of GPNAB.
  • Ensuring that Glenmark Nordic`s business in narcotics and controlled / psychotropic pharmaceuticals operates in accordance with SE legislation.
  • Support the GPNAB team during local inspections.
  • Ensuring the performance of self-inspections and management reviews on a periodic basis.
  • Ensuring that a QMS is implemented and maintained in compliance to EU Guideline 2013/C343/01, local legislation and Glenmark EU QMS.
  • Support in the preparation and monitoring of Distribution Technical Agreements.
  • Keeping appropriate records of any delegated duties.

Specifically, the post has the authority to:

  • Take decisions about handling of products and stop distribution if needed.
  • Contact Person for Medical Products Agency (MPA) and reporting to MPA about serious deviations, complaints, recalls, changes, possible falsified products etc.
  • Approving/disapproving QA documents from the Quality Management System, Risk Management processes, Change Control processes, Deviation reports, validations concerning GDP processes.
  • Implement changes according to GDP/GMP, legislation and guidelines.
  • Support European projects to ensure adequate and timely implementation.

COMPETENCE REQUIREMENT AND ABILITIES

Educational Qualifications:

  • Life Science degree (Pharmacy, Biology, Chemistry)

Experience:

  • Minimum 5 years’ experience in a pharmaceutical distribution quality environment with knowledge of GDP and warehousing / customer service experience.
  • Previous experience in a similar Quality and/or PV / device vigilance role within a pharma or medical devices environment.
  • Previous experience of pharmaceutical or medical device distribution quality environment with knowledge of GDP and warehousing / customer service experience.
  • Basic knowledge of pharmaceutical wholesale or manufacturing quality environment with knowledge of GMP and production experience (desirable).
  • GDP Auditing experience (not essential).

Knowledge and Skills (Functional / Technical):

  • Attention to details.
  • Analytical thinking and problems solving.
  • Ability to prioritise effectively and to multi-task.
  • Fluent in English and Swedish.
  • Basic knowledge of Finnish (desirable), Danish or Norwegian.
  • Broad understanding of regulatory requirements and specifics in the Nordic markets with emphasis on the Swedish market.
  • Strong project management skills.
  • Knowledge, judgment, and confidence to make decisions when faced with ambiguity.
  • Must be able to operate calmly and effectively under pressure.
  • Resilient, pragmatic, and hardworking.
  • Structured thinker.

WHAT GLENMARK PHARMACEUTICALS, NORDIC CAN OFFER

Glenmark Pharmaceutical, Nordics, offers the unique charm of a smaller company within a larger organization, fostering an environment that encourages initiative and creativity. Here, you are empowered to shape and develop your work through your own ideas and initiatives. You become part of a close-knit team that deeply cares about the work environment and collaboration, creating a space where employees genuinely want to stay.

You will be working in a faced paced environment where changes and improvements are part of your daily work environment. We are constantly adapting towards the patients’ needs which can be characterized by an entrepreneurial approach. We are a small team with specialists in every area where you will have the full responsibility for QA for the Nordic organization. You will need a flexible and open mind set in order to manage your day-to-day operations as well as the ability for long term planning.

As a valued team member, you will be involved and gain meaningful insight into the company’s operations and business progress, thanks to an open culture characterized by significant transparency. This approach ensures that every individual feels connected to Glenmark’s broader goals and contributes to the collective success.

More information, please contact;

Adina Lekberg Salamon, +46 73 974 43 34, [email protected]

Anders Larsson, +46 73 203 46 91, [email protected]

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