Senior Specialist, TPM QA
Apply NowCompany: Synectics Inc.
Location: North Chicago, IL 60064
Description:
Responsibilities
Requirements :
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.
- Responsible for managing the quality oversight of assigned small molecule pharmaceutical products manufactured at external partners, to ensure business objectives are met with regards to on time delivery of products while assuring compliance with policies and standards, as well as external agency regulations.
- Develops in concert with the cross functional team, the appropriate strategies for product transfers.
- Management oversight for project activities at TPMs to achieve on-time quality deliverables.
- Driver for the quality and compliance aspects of product packaging transfers.
- Participates in the development of global Product Quality Assurance strategies to support pharmaceutical products produced at third party manufacturing (TPM) facilities.
- Implements agreed strategies.
- Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for pharmaceutical products and elevates medium and high-risk events to management.
- Establishes and maintains relationships and open communication with Third Party Manufacturers, affiliates and other functional groups to maintain roles and responsibilities.
- Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks.
- Provides support for quality audits.
- Supports pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
- Supports the management of exception documents and Corrective and Preventive Actions.
- Manages change plans tasks related to packaging process transfers to ensure timely and compliant execution, including but not limited to QTA updates, specification and Master Batch records setting, equipment qualification reviews, process validation approval, timely stability initiation...
- Support Audits
- Review and approve TPM PQRs and/or APRs
- Lead/Contribute to investigations at TPMs
- Support packaging transfer projects and activities at TPMs
Requirements :
- Equipment Engineering
- Validation / Qualification
- Manufacturing
- Packaging experience a plus
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.