Qc Lead Site Krems

vor 2 Wochen

Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

Job Description:

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio pharmaceuticals worldwide.

Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

For our site in Krems, we are currently looking for a:

QC Lead Site Krems (M/F/d)


Lead the QC Laboratory Team and establish / maintain the Quality Control Laboratory according to Austrian Drug Law (AMG), European GMP, and USDA at the our Site in Krems, Austria.


Responsibilities
Operational Management

  • Manage the execution of the operational QC lab processes based on daily walkthroughs and visual management
  • Clarify operational status to others in production team and ensure problem solving within operational and quality procedures and guidelines
Planning

  • Assure availability right number of employees (both qualitative and quantitative)
  • Manages the portfolio of QC and takes preventive and or corrective action in case of priority clashes
  • Contributes to the development of the QO profit plan
Compliant team process

  • Monitor daily process, indicate, and investigate incidents/OOS. Authorizes solutions and ensure solutions are implemented
Financial Analysis / Key Performance Indicators

  • Prepare monitor and control budgets for QC lab
  • Initiate continuous improvement projects to improve the financial performance of the QC labs and the COG of the site's product portfolio
  • Analyze actual financial performance, compare to plan, and identify variances. Ensure update for Key Performance Indicators
  • Contribute to delivery of budget QO and realization of financial targets
Improvements

  • Initiate and contribute to improvement projects
  • Initiate and sponsor Lean lab improvement activities
  • Responsible for implementation in cooperation with Improvement Engineer and production team
  • Responsible for benchmarking
Change Management

  • Formulate change management proposals and authorize changes in cooperations with QO and IPT members
Documentation

  • Monitor, initiate and ensure administration of data (e.g., performance indicators) and documentation (e.g., SOP's), according to procedures and guidelines
People Management

  • Contribute to the recruitment and retaining of employees, the development and execution of training programs and the execution of all performance management activities
  • Leaders are coaches & teachers
  • Live inclusive behaviors and create a safe environment
  • In cooperation with HR, within HR procedures and guidelines
  • Results in developed and empowered employees and contribution to the required level of the team
SHE responsibility

  • Managers are responsible for the realization of our corporate policy on safety, health, and environment. Therefore, they must create working conditions that make it possible for their workers to comply with all relevant EHS legislation and company requirements. They must supervise their workers in being compliant and must initiate and support improvement in SHE performance. Managers must demonstrate personal commitment with respect to working safely, healthy, and environmentally friendly
Inspections

  • Act as primary QC representative during inspections by regulatory agencies
  • Accompany regulatory inspections in the labs
  • Responsible for timely response and corrective action on any regulatory citations

Education/knowledge/experience

  • Academic level
  • Minimal 5 years of experience within QC and manager level
  • Go to Gemba
  • Green Belt certification or similar
  • Passion for lean and willing to make personal change
  • Able to articulate case for change and understands importance of enrollment

Who we are


We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.

For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.

Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.


What we look for


Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.

Here, you have that opportunity.

You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.


Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Yes

**Travel Requireme

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