Equipment Qualification Expert (Pharma)

Job title: Equipment Qualification Expert

Duration: 6 Months

Location: Indianapolis, IN 46268

Starting Rate: $50/hr

Job Details:

• Writing equipment qualification and validation master documents e.g. User Requirements, Design Specifications, Configuration Specifications, Software Specifications, etc.

• Generating equipment commissioning and qualification protocols including SAT, IQ, OQ & PQs preferably in a paperless system (KNEAT)

• Execution of qualification and validation test scripts in line with the qualification/validation plan, and protocols using paperless qualification software, Kneat.

• Following procedures of qualification/validation as well as good documentation practices.

• Recording excursions/deviations from the protocol (if any) and performing root cause analysis to determine root causes and resolutions,

• Working with associates in engineering, quality, and project management to timely resolve all issues and closed documents on time

• Writing validation summary reports and release of systems to the next step.

• Working with equipment vendors and other technical support to complete qualification work seamlessly and timely

• Adherence to project expectations in terms of timeline and deliverables.

• Adherence to procedures of HSE, GMP as well as project management and compliance.

Major Accountabilities:

• Drafting, reviewing, and pre-approval of protocols in a timely manner

• Adherence to GDP (Good Documentation Practices), Data Integrity, and other relevant SOPs.

• Adherence to the overall project schedule

• Ensure all commissioning and qualification protocols are compliant to quality manual and site procedures.

• Fosters an environment that enables the most efficient and effective work processes to achieve project objectives and milestones.

• Implementation of and compliance with all the guidelines and requirements for safe work, environment protection and property protection.

Key Performance Indicators – KPIs

• Timely and complete commissioning and qualification packages for the systems.

• Adherence to project schedule of activities

• Compliance with Quality Manual and RLT Site SOPs.

Job Dimensions:

Number of Associates:

Direct reports: None

Indirect reports: Expected to influence and interacts at various level of the project organization

Financial responsibility: None

Impact on the Organization: Moderate impact on the organization due to appropriate project execution

Ideal Background:

Education: Minimum: Degree in Science and Certification in Project Management (preferred). Extensive project management experience may substitute the need for a degree.

Languages: Fluent in English

Experience: • High performing, credible professional, with a track record of successfully coordinating cross functional projects and teams.

• Cultural awareness and sensitivity; ability to network and communicate with various levels of the organization.

• Fair understanding of technical and business principles and processes of medicine manufacture and regulatory requirements attained in various functions / areas of pharmaceutical industry.

• 6 years project management experience, of this, ?2 years within similar role and complexity; experience in Health Care / Pharma Industry preferred

• Strong planning capabilities (decision making, result oriented, challenge capability, negotiation, supporting others, stakeholder mgt, change mgt, working in a matrix organization)

• Strong proficiency in Microsoft Excel, PowerPoint, and MS Project

• Strong verbal communication and presentation skills

• Flexibility and adaptability to change.

• Learning agility and ability to work in a complex and rapidly changing environment.

• Basic understanding of regulatory and legal requirements