Full Time Contract
Title or Role: QA (CAPA) Specialist
Location: Halle/Westphalia, Germany, 100% on-site
Length of Contract: 6 months
Company Description:
Our client is a global biotech drug manufacturer located in the USA and Germany.
The manufacturing sites are state-of-the-art aseptic processing facilities equipped with advanced technology and equipment to ensure the safety and quality of the products manufactured following USA and Europe regulations. They have the ability to produce a wide range of biologics, including monoclonal antibodies, recombinant proteins, and other complex therapies.
Position Description:
The Specialist assures that all deviations, CAPAs, and change controls are documented, analyzed, resolved, reviewed and approved in time and in compliance with regulatory requirements and company standards. Responsible for leading the completion and closing thorough investigation, deviations and CAPAs within the pharmaceutical manufacturing process and QC laboratory operations. Addresses quality issues within the pharmaceutical manufacturing process.
Responsibilities:
* Lead and coordinate investigations of deviations, non-conformances, and quality incidents in the manufacturing process.
* Conduct root cause analysis using various methodologies to identify underlying issues and propose effective corrective and preventive actions.
* Document investigation findings, conclusions, and CAPAs in a clear and concise manner.
* Collaborate with cross-functional teams, including Production, Quality Control, Engineering, and Technical Service, to gather relevant information and ensure timely resolution of deviations, CAPA, and Changes Controls.
* Ensure all investigations and CAPAs are closed in full compliance with applicable USA and European regulations and maintain consistent functionality throughout their operational life.
* Develop and implement CAPAs to prevent recurrence of deviations and improve overall process quality.
* Lead and manage the change control process, including the evaluation, documentation, approval, and implementation of changes.
* Conduct risk assessments and impact analyses to identify potential risks and develop mitigation strategies.
Qualifications:
* Experience in pharmaceutical manufacturing, with at least 5 years in a quality compliance or quality assurance role.
* Strong knowledge of USA and European and other relevant regulatory requirements.
* Proven experience in conducting root cause analysis and implementing, reviewing and approving CAPAs documentation.
* Proven experience in managing change CAPAs documentation closing processes.
* Excellent analytical, problem-solving, and decision-making skills.
* Strong written and verbal communication skills.
* Ability to work effectively in a team environment and collaborate with cross-functional teams.
* Detail-oriented with a strong focus on quality and compliance.
* Proficiency in using quality management systems (QMS), investigation tools, and change management tools.
Education & Certifications:
* Bachelor's degree in science or engineering.
* Certification is preferred in quality management or related areas (e.g., Six Sigma, ASQ).
Equal Opportunity Statement:
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.
Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
About RCM:
RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.