Quality Control Manager, STO

West Pharmaceutical Services; Stolberg; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Nordrhein-Westfalen is searching for a Quality Control Manager. In this role, you will oversee the Quality Control team, ensuring compliance with regulations and leading quality inspections. The ideal candidate will have at least 8 years of experience in Quality Control and hold a relevant degree. This position emphasizes leadership and effective communication skills as part of a commitment to maintaining high standards.

Qualifikationen

• Minimum 8 years previous experience in Quality Control required.
• Experience in FDA regulated environment, pertinent to ISO 15378 preferred.
• Must be familiar and proficient with computers and various software.

Aufgaben

• Manage the Quality Control team to ensure inspections are timely and accurate.
• Ensure compliance with quality system documents and FDA regulations.
• Supervise personnel issues and conduct performance evaluations.

Kenntnisse

Team leadership

Quality Control procedures

Data analysis

Communication skills

Problem-solving

Ausbildung

Associate's Degree in Technical or Engineering

Bachelor's Degree in Technical or Engineering

Tools

Microsoft Word

Microsoft Excel

Master-control

SAP

Jobbeschreibung

Overview

This is an onsite position requiring the team member to be onsite for 4 days per week.

No relocation is provided for this opportunity

Who We Are

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

In this role, you will monitor and control the daily activities of quality inspections of incoming, in-process, final, and batch record review and release. In this position, you will manage the Quality Control team to ensure inspection process is executed in a proper and timely manner by ensuring procedures are followed and improved as part of a continuous improvement mindset.

Essential Duties and Responsibilities

• Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.

• Direct reports include quality control supervisors

• Leads and directs the Incoming Inspection, In-Process Inspection, and Batch Release teams with a positive and patient attitude.

• Maintains and instills in others a “quality at the source” mentality as it pertains to all aspects of manufacturing, including documentation, training, and other functions related to production.

• Maintains and instills in others an “immediate audit readiness” mentality so that records and actions are executed in a way that ensures their accuracy, legibility, and immediate retrievability.

• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.

• Schedule and prioritize quality inspection, testing, and batch record review and release to support Operations and release of product.

• Identifies and develops opportunities to improve existing processes and procedures

• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.

• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.

• Manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished.

• Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non-Conformance Report is required.

• Manages the development of documentation and procedures during the qualification of new equipment/inspection methods.

• Exhibits regular, reliable, punctual and predictable attendance.

• Creates, prepares, implements and improves Quality Control KPIs metrics.

• Determines/sets Goals and Objectives for the Quality control organization and training programs for team's development purposes.

• Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.

• Ensures equipment is up to date on Preventive maintenance and calibration activities.

• Maintains the QC area well organized with a 5S mindset.

• Other duties as assigned

Additional Responsibilities

• Participate in special project teams as assigned.

• Performs other duties as assigned based on business needs.

• Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.

• Exhibits regular, reliable, punctual and predictable attendance.

Education

• Associate's Degree in Technical or Engineering required

• Bachelor's Degree in Technical or Engineering preferred

Work Experience

• Minimum 8 years previous experience in Quality Control required

• Experience in FDA regulated environment, pertinent to ISO 15378 preferred

Preferred Knowledge, Skills and Abilities

• Must be familiar and proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Master-control, SAP

• Able to comply with the company’s safety policy at all times

• Able to comply with the company’s quality policy at all times.

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target

• Metrology Equipment experience

• Leadership experience in leading teams preferred

Travel Requirements

5%: Up to 13 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements

• This job requires decision making based on data analysis

• Must be able to generate, express, and exchange new ideas

• Must be able to understand direction and adhere to established procedures

• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures

• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities

• Read and interpret data, information and documents

• Must maintain the ability to work well with others in a variety of situations

• Must be able to multi-task, work under time constraints, problem solve, and prioritize

• Ability to make independent and sound judgments

• Observe and interpret situations, analyze and solve problemsAdaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events.

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West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [e-mail]. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.