Product Quality Manager

1 week ago

Stockholm, Stockholm, Sweden TN Sweden Full time

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Karo Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 80 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A. Since 2019, under EQT ownership, we're rapidly heading towards a €1 billion European leadership position in consumer health.

Join us at Karo Healthcare on our exciting journey. We're currently looking for a Product Quality Manager for our office in Stockholm.

Tasks and Responsibilities:

  • Supplier evaluation, qualification, management and control. Act as QA representative in Technology Transfer projects, including work with validation at suppliers from Karo's perspective.
  • Take on a Project Leader role for some projects but also help within QA to set up structures for a project driven work within the function.
  • Ensuring compliant and efficient processes to verify supplier control in the Karo Global QMS.
  • Securing efficient compliance to global processes and assuring relationship building with Karo supplier base together with the team of QA and operations.
  • Manage the CMOs in accordance with compliance to GDP and GMP as well as directive 2001/83/EC. Assurance of PQR management, change control and CAPA management in accordance with QMS. Responsible for product compliance after release but also prior to release upon deviation in production and follow up of the same.
  • Act as a process owner of some of the Global QA team's processes.

Authorities:

  • Ensuring product compliance 2001/83/EC in outsourced activities.
  • Audit planning, lead auditor and audit report sign off.
  • Participate as auditor in internal audit program.
  • Approve and close deviations.
  • Approve and close change controls.
  • Approve PQRs, specification, analytical methods, stability protocols and reports, manufacturing instructions, validation protocol and reports and similar GMP documents issued by our CMOs.
  • Issue and/or approve regulatory documents (Modul 3).
  • Co-sign on QA-Agreements when it is applicable.

The delegation is not applicable for the following responsibilities:

Deciding on the final disposition of returned, rejected, recalled or falsified products or approving any returns to saleable stock.

Requirements:

  • Education: Bachelor's degree in a scientific or technical field required; Master's degree in Pharmacy, Medicine, Chemistry, or Chemical Engineering preferred.
  • Experience: At least 5 years in the pharmaceutical or medical devices industry.
  • Language Skills: Fluency in English is essential; Swedish is a plus.
  • Professional Skills and Attributes:
  • Strong alignment with Karo values: professionalism, honesty, accuracy, and integrity.
  • Committed to ethical conduct, following rules and regulations.
  • Proactive, team-oriented, with a 'can-do' attitude.
  • Ability to work independently and collaboratively within a multidisciplinary team.
  • Pragmatic, accurate, flexible, and willing to seek and offer support when needed.
  • Opportunity to create, grow, and encourage.

Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions. Flexible schedule, hybrid model with the primary workplace in the office, and life-work balance. Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry. Very positive work environment in a dynamic, international, and motivated team. Start-up spirit while being a part of a large international organisation with strong values.

Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.

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