Commissioning & Qualification (C&Q) Specialist Job at Cencora (Aguadilla)

Job Description

The consultant will deliver technical support for Commissioning, Qualification, and Validation (CQV). The CQV consultant is accountable for all CQV-related activities. This includes providing an update on the status of each document. The validation service will serve as the primary means to ensure that the schedule remains on track. The validation consultant should notify the project manager of any risks that could impact on the project plan and should provide support during project meetings.

Job Responsibility

Review CQV documents following standards and procedures
CQV Protocols development, execution coordination, execution, interpretation, approval, and report generation
Relocation activities
Develop CQV assessments
User Requirement development and approval
Functional Requirement & Design Specifications development and approval
Develop CQV Plan
Generate, review, get approval, and manage new SOPs and/or modify existing ones as required
Owns, generates, reviews, gets approval, and manages Change Controls as required
Performs validation assessments as part of the change control process and verify with the Change Owner and/or System Owner that there is no change control records in progress that could impact on the same validated system before the start of each validation exercise
Other CQV tasks may be assigned as needed
A statistical consultant is requested for the design of experiments (DOE). This field of applied statistics focuses on the planning, execution, analysis, and interpretation of controlled tests. The aim is to evaluate the factors that influence the value of a parameter or group of parameters

Requirements

Bachelor’s degree in Engineering or a Scientific field
5+ years of experience in a regulated industry
Strong knowledge of cGMP/FDA regulations
Ability to develop and adhere to self-directed standard work-organized and methodical with minimal guidance and be comfortable working as an individual and part of a team
Exercises Good Judgment and Drives Change for Competitive Advantage
Strong written and oral communication skills and ability to collaborate effectively with others
Strong interpersonal, leadership and influencing Skills, communication and motivation
Drives for Superior Results and Passion to Win with demonstrated record in getting things done
Inspires Continuous Improvement

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families
backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions
paid parental leave
paid caregiver leave
variety of training programs
professional development resources
opportunities to participate in mentorship programs
employee resource groups
volunteer activities

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Commissioning & Qualification (C&Q) Specialist

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