GMP Planning & Compliance Specialist

Jobtailor; Luzern; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a qualified QA professional to own deviation records, lead CAPA actions and support change controls in a GMP-regulated setting.

You will create and maintain SOPs, perform calibration/qualification activities, and investigate issues with root-cause analyses. Collaboration with cross-functional teams and audits readiness are essential in this role.

Qualifikationen

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Pharmacy, or related field.
• Several years of experience in a GMP-regulated pharmaceutical, biotechnology, or clinical manufacturing environment.
• Hands-on experience in deviation management, change control, CAPA management and SOP/documentation processes.
• Practical knowledge of calibration, validation and qualification activities for equipment and systems.
• Strong technical problem-solving skills with the ability to work independently and make sound decisions within established procedures.
• Solid understanding of GMP requirements and quality risk management principles.
• Fluent in English, written and spoken; additional language skills are an advantage.
• Comfortable managing multiple priorities in a fast-paced and regulated environment.
• Experience with systems such as SAP, ProCal, eVal, DeltaV, Veeva Vault, MEDS, or eShop Floor is considered an advantage.

Aufgaben

• Own and coordinate deviation records, supporting timely investigations and effective CAPA implementation.
• Support and monitor change control activities to ensure compliant and efficient implementation of process and system changes.
• Create, maintain and improve Standard Operating Procedures (SOPs) and Good Manufacturing Process (GMP) documentation that support robust and inspection-ready operations.
• Execute calibration, validation and qualification activities for equipment and systems in accordance with approved standards and procedures.
• Investigate technical issues, perform root‑cause analyses and help implement sustainable corrective actions.
• Perform quality risk assessments to support sound decision‑making and maintain a high level of compliance.
• Partner with cross‑functional stakeholders to support audits, inspections and ongoing readiness activities.
• Contribute to improvement projects that enhance compliance, system performance and operational efficiency.
• Support Environmental Health & Safety activities, including Management of Change, where applicable.
• Ensure accurate, complete and timely technical and quality documentation across assigned responsibilities.

Kenntnisse

Deviation Management

Change Control

CAPA Management

GMP Compliance

Quality Risk Management

Technical Problem-Solving

SOP Documentation

Strong Decision-Making

Independent Work

Managing Multiple Priorities

Ausbildung

Bachelor's or Master’s degree

Tools

SAP

ProCal

EVal

DeltaV

Veeva Vault

MEDS

EShop Floor

Jobbeschreibung

• Own and coordinate deviation records, supporting timely investigations and effective CAPA implementation
• Support and monitor change control activities to ensure compliant and efficient implementation of process and system changes
• Create, maintain and improve Standard Operating Procedures (SOPs) and Good Manufacturing Process (GMP) documentation that support robust and inspection-ready operations
• Execute calibration, validation and qualification activities for equipment and systems in accordance with approved standards and procedures
• Investigate technical issues, perform root-cause analyses and help implement sustainable corrective actions
• Perform quality risk assessments to support sound decision-making and maintain a high level of compliance
• Partner with cross-functional stakeholders to support audits, inspections and ongoing readiness activities
• Contribute to improvement projects that enhance compliance, system performance and operational efficiency
• Support Environmental Health & Safety activities, including Management of Change, where applicable
• Ensure accurate, complete and timely technical and quality documentation across assigned responsibilities

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Pharmacy, or a related field preferred
• Several years of experience in a GMP-regulated pharmaceutical, biotechnology, or clinical manufacturing environment
• Hands-on experience in deviation management, change control, CAPA management and SOP/documentation processes
• Practical knowledge of calibration, validation and qualification activities for equipment and systems
• Strong technical problem-solving skills with the ability to work independently and make sound decisions within established procedures
• Solid understanding of GMP requirements and quality risk management principles
• Fluent in English, written and spoken; additional language skills are an advantage
• Comfortable managing multiple priorities in a fast-paced and regulated environment
• Experience with systems such as SAP, ProCal, eVal, DeltaV, Veeva Vault, MEDS, or eShop Floor is considered an advantage.

Core Competencies

Demonstrates expertise in deviation management, change control, and CAPA implementation within GMP-regulated environments, ensuring compliance and operational efficiency. Proficient in creating and maintaining SOPs and quality documentation while supporting audits and inspections.

Highest-signal resume keywords

• Deviation Management
• Change Control
• CAPA Management
• GMP Compliance
• Quality Risk Management

ATS Optimization Keywords

Hard Skills

• Deviation Management
• Change Control
• CAPA Management
• Calibration Activities
• Validation Activities
• Qualification Activities
• Quality Risk Assessment
• Technical Problem-Solving
• SOP Documentation
• GMP Requirements

Soft Skills

• Strong Decision-Making
• Ability to Work Independently
• Comfortable Managing Multiple Priorities

Industry Keywords

• Life Sciences
• Pharmaceutical
• Biotechnology
• Clinical Manufacturing
• Environmental Health & Safety

Tools & Technologies

• SAP
• ProCal
• EVal
• DeltaV
• Veeva Vault
• MEDS
• EShop Floor