Manager - QA
Our Global client is looking to hire as the former incumbent of this position has taken on a new role within the organization. The position will pay between $80-$110K + bonus eligibility. Our client will offer a relocation package, as appropriate. This position is located in a suburban location just outside of Buffalo, NY. MUST HAVE PHARMACEUTICAL MANUFACTURING EXPERIENCE!
* Ensure projects' time-lines and budgets are met and any deviations are timely communicated to senior site management
* Thorough review and analysis of deviations which may include both quality and manufacturing deficiencies.
* Reviews and approves product development reports. i.e.: filter retention studies, product hold times, paraben concentration studies and product stability.
* Approval and analysis for evaluation of defect levels
* Reviews cleaning validation studies to support the effectiveness of current cleaning programs.
* Provide assistance in troubleshooting in both manufacturing and quality related issues.
* Approval of validation qualifications/re-qualifications.
* Support new product development and manufacturing initiatives
* Reviews and approves standard operating procedures
* Approval of environment excursions and anomalies.
* Analyze and approve new manufacturing processes and innovations
* Performs first of code batch record review.
* Review and approve work orders and critical change requests
* Follow up and monitor action plan effectiveness evaluation and review
* Approve document change control request
* Assess, evaluate, and determine compliant course of action for any of the following areas as they relate to project, investigation or process improvement: Engineering, Chemistry, Microbiology, Computer part 11, Solid and Liquid Manufacturing, Sterilization Assurance and Aseptic Manufacturing
* Responsible for internal documentation meeting minimum cGMP requirements.
* Coordinate with FDA during inspection processes.
* Approve, create and/or revise validation, engineering, laboratory, and database documents to ensure the documentation is accurate, complete, thorough, cGMP compliant, and meets various external requirements (i.e., ISO, GAMP, ISPE, etc.).
* Research, investigate, and provide guidance to the team concerning technology, compliance, quality, and creative solutions to ensure the project or investigation are
* Review and advise on risk assessment for all areas of the facility management, from construction & remodeling to product & cross-contamination
* Ensure validation activities are performed in accordance with SOPs and regulatory compliance
* Ensure facility engineering, PM & calibration programs are performed in appropriate & timely manner.
* Ensure investigations are completed in a timely manner and are cGMP compliant
* Ensure regulatory guidance updates are transitioned into appropriate procedures, practices, policies and activities in a timely manner.
* Ensure validation programs/methods for computer/ laboratory equipment are performed in accordance with SOP's and other regulatory requirements
* Review and approve quality documents such as: Batch Records, Product Specifications & Test Methods, Masterplans, IQ/OQ/PQ's, PV, CV, CSV's, DQ, URS, FAT/SAT's, Drawings/P&IDs, and Policies/SOP's.
* Make Quality Assurance related decisions at a leadership level within the plant from the technical review for various quality areas.
* BS/BA degree is required. 10-15 years of related work experience in a pharmaceutical industry with an emphasis on cGMP are required if no BS/BA degree is attained. At least 7-10 years of industry experience with BS/BA
* Must possess strong interpersonal and written/verbal communication skills
* Must be able to interface with Regulatory Agencies, Vendors and other departments across the Company