CQ Documentation Preparation Lead

at  Callista

We are seeking an experienced CQ Documentation Preparation Lead to join our engineering team at our Visp site. The successful candidate will be responsible for managing the preparation, consistency, and approval of Commissioning and Qualification (CQ) documentation to support key projects within the pharmaceutical and biotech industries. This role requires a deep understanding of GMP regulations, as well as proficiency in COMOS and KNEAT platforms.

Key Responsibilities:

• Ensure consistency and quality of all documentation across the CQ group.
• Manage interfaces between COMOS, KNEAT, and other DMS (Document Management Systems) for CQ documentation.
• Lead the creation and management of documentation templates, including “first-of-kind” documents, ensuring alignment across the CQ group.
• Oversee the approval process for documentation, ensuring proper retention and compliance with internal standards.
• Coordinate the preparation and approval of Operational Qualification (OQ) protocols, ensuring their release for OQ and Performance Qualification (PQ) activities.
• Ensure compliance with cGMP regulations and coordinate training programs for Commissioning and Qualification activities.
• Liaise with internal and external resources for effective Qualification and Documentation Management.
• Self-manage the review and approval process for CQ development using COMOS/KNEAT platforms.

Candidate Requirements:

• Bachelor’s degree in Life Sciences or Engineering.
• At least 6+ years of experience in commissioning, qualification, and validation (DQ, IQ, OQ, Commissioning) within the pharmaceutical or biotech industries.
• Strong understanding of cGMP and regulatory requirements.
• Proficient in using COMOS/KNEAT platforms.
• Excellent written and verbal communication skills in English.
• Strong organizational skills and ability to work independently and manage multiple projects.

This is a fantastic opportunity to be part of a dynamic team where you will contribute to the delivery of high-quality projects in a regulated environment. You will be at the forefront of ensuring compliance and documentation excellence, supporting critical Commissioning and Qualification activities

• Ensure consistency and quality of all documentation across the CQ group.
• Manage interfaces between COMOS, KNEAT, and other DMS (Document Management Systems) for CQ documentation.
• Lead the creation and management of documentation templates, including “first-of-kind” documents, ensuring alignment across the CQ group.
• Oversee the approval process for documentation, ensuring proper retention and compliance with internal standards.
• Coordinate the preparation and approval of Operational Qualification (OQ) protocols, ensuring their release for OQ and Performance Qualification (PQ) activities.
• Ensure compliance with cGMP regulations and coordinate training programs for Commissioning and Qualification activities.
• Liaise with internal and external resources for effective Qualification and Documentation Management.
• Self-manage the review and approval process for CQ development using COMOS/KNEAT platforms