Teamlead Quality in Operations/ Packaging an Release (m/f/d) [Austria]

 

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Job Description

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Our site in 1210 Vienna is a strategic location for solid drug manufacturing including tablets, coated tablets, granules and implants for the health provision and treatment of livestock and domestic animals. Most of our products are exported. To ensure sustainable company growth we continually strive to offer attractive career opportunities for more than 450 employees at our Vienna site. In support of our existing team, we are currently looking for:

Teamlead Packaging and Release (m/f/d)

Main Responsibilities:

• Leading and coaching a Quality team of approximately 5 Quality Assurance experts (incl. Qualified person) in ensuring the highest standards of quality and compliance in our packaging operations. Your primary focus will be on batch release and issuance, while also overseeing packaging-related projects, deviations, complaints and changes.

• Ensure compliance with all applicable regulations, guidelines, and company policies related to packaging processes and batch release. Supporting a state of readiness for Health Authority, internal and divisional audits as needed.

• Oversee the batch release process, ensuring timely and accurate release of finished products for distribution.

• Collaborate with cross-functional teams, including production, supply chain, and regulatory affairs, to resolve any batch-related issues promptly.

• Support change management initiatives within the packaging departments, ensuring smooth implementation of process improvements, equipment changes, and regulatory updates.

• Collaborate with relevant stakeholders to assess the impact of proposed changes, develop implementation strategies, and ensure effective communication to all team members.

• Provide support and guidance to the team in deviation management, including investigation, root cause analysis, and implementation of corrective and preventive actions.

• Collaborate with Production Quality Complaints (PQC) team to address quality issues, support investigations, and implement improvement measures.

Requirements

• Master’s degree in natural sciences like chemistry of pharmacy. Technical background in related fields like pharmaceutical engineering, pharmaceutical technology, bioprocess engineering or process engineering.

• Qualified Person (QP) certification or the ability and willingness to become a Qualified Person.

• Prior experience working in a pharmaceutical manufacturing environment and experience with batch release process is a plus

• Proven leadership and people management skills, with the ability to motivate and inspire a team

• Strong knowledge of regulatory requirements, quality standards, and industry best practices related to packaging processes and batch release in pharmaceutical industry.

• SAP-,Artis-, Trackwise- or Reliance- knowledge is advantage

• Hands-on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools preferred

• Exceptional social and communication skills with the ability to build and maintain strong relationships with other departments, such as production, supply chain, and regulatory affairs. Fluent in English and German is a must.

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 51.600, - and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Requirements

• Master’s degree in natural sciences like chemistry of pharmacy. Technical background in related fields like pharmaceutical engineering, pharmaceutical technology, bioprocess engineering or process engineering.
• Qualified Person (QP) certification or the ability and willingness to become a Qualified Person.

• Prior experience working in a pharmaceutical manufacturing environment and experience with batch release process is a plus
• Proven leadership and people management skills, with the ability to motivate and inspire a team
• Strong knowledge of regulatory requirements, quality standards, and industry best practices related to packaging processes and batch release in pharmaceutical industry.
• SAP-,Artis-, Trackwise- or Reliance- knowledge is advantage
• Hands-on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools preferred
• Exceptional social and communication skills with the ability to build and maintain strong relationships with other departments, such as production, supply chain, and regulatory affairs. Fluent in English and German is a must.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Flex Time

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Requisition ID:R255497

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