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Analytical R - Levittown, United States - Apozealpharma
Description
Analytical R & D/Quality Control Director
APOZEAL is a pharmaceutical company that is focused on the development and manufacturing of high-quality branded and generic pharmaceuticals across a broad range of therapeutic areas.
Title:
Analytical R & D/Quality Control Director
Department:
Quality
Location:
Levittown. PA
Position Summary
The Analytical R & D Quality Control Director is responsible for overseeing all AR&D & QC Operations to ensure drug products manufactured and distributed by Apozeal Pharma meet all Quality and Compliance requirements.
Provide the necessary direction and supervision for a dynamic and changing environment which requires quick thinking when problems arise. Maintain cost control over operational spending. Support the site management to ensure the achievement of the organizations business goals.Primary goal will be to work with Apozeal leadership to prioritize initiation/start up and qualification of all equipment's & instruments in the entire AR & D & QC Labs to re-start manufacturing/packaging/distribution of all products at Apozeal site at 2091 Hartel St.
Levittown PA.Essential Functions & Key Responsibilities
Responsible for management and oversight of the Quality Control Laboratory to ensure that all aspects comply with GMP, GDP, legal and regulatory requirements.
Responsible for managing all testing activities including but not limited to, raw materials packaging components, in-process, finished product (primarily liquids and suppositories), stability, cleaning verification/validation, and method transfer.
Responsible for ensuring the appropriate documentation and processes are in place (SOPs, Specifications, Methods, Protocols, Reports, etc.)Responsible to ensure QC testing and other testing reports are reviewed for accuracy, completeness and compliance to requirements to ensure that quality standards.
Responsible for ensuring and overseeing compendial review activities.Responsible for ensuring laboratory efficiency, and appropriate scheduling
Maintain all laboratory notebooks, reports, instrument logbooks and other documentation in accordance with CGMP.
Responsible for implementing and maintaining a QC analyst certification program and ensuring SOP and GMP training is completed for all laboratory personnel.
Implement & improve laboratory procedures to achieve highest level of compliance.Conduct and assist in laboratory investigations, deviations and change controls.
Foster a team atmosphere for great performance and synergy in the work group
Ensure proper document management and record keeping.
Coordinate with certifying bodies and represent site during certifications or audits.
Communicate to top management on Quality System issues, non-conformities & Audit reports
Generate and maintain Quality Control metrics.
Lead the team during internal, external and regulatory audits.
Provide support to other site disciplines to achieve common business goals.
Maintain good communication on pertinent/important matters with all in the organization.
Ensure compliance to all company policies, procedures, safety standards and government laws.
Work with cross-functional teams on project development and continuous improvement.
Additional responsibilities as needed.
Candidate Requirements
A minimum of a MS in Chemistry or related science discipline.
The Quality Control/Assurance Director should have at least 5 to 7 years of QC Laboratory experience. Must have 2-3 years of supervisory/management experience.
The Quality Control Director must be highly skilled in supporting a manufacturing operation.
Thorough understanding of cGMP, GLP, GDP, USP, FDA guidance documents and ICH guidelines
Working knowledge of lab instrumentation such as HPLC, GC, IR, UV, refractometer, KF, etc., and associated techniques.
Must have knowledge and experience with computerized data and analysis systems, such as Waters Empower.
Must have a teamwork attitude
Strong math, statistics, and computer skills.
Excellent organization and communication skills and must be able work collaboratively with other Must be comfortable working in a factory, warehouse, and office setting.
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