Equipment Qualification Expert

Job Description

Job Description

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 paperless system (KNEAT)

Execution of qualification and validation test scripts in line with the qualification / validation plan, 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 cause 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 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.

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 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.

Qualifications :

Minimum : Degree in Science and Certification in Project Management (preferred).

Extensive project management experience may substitute the need for a degree.

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

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.

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

Languages : Fluent in English

Benefits :

Healthcare Insurance : Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance : Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan : The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus : Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.