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Form of work Description/Comment: FLEX HYBRID - DURATION - 1 YEAR - SHIFT - M-F 8-5PM
The Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control
The QA Product Manager for VMS (Vitamins Minerals and Supplements) products provides customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent St. Petersburg's customers and internal organizations. This position serves as a representative for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change controls and associated Master documents, including but not limited to MERs and material Specifications; Product specifications; Test methods; Master Batch Records; Master Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance and Calibration work order requirements for critical systems.
CUSTOMER FOCUS
Primary quality liaison for clients and internal customers. Is expected to become the Subject Matter Expert for the client products, processes and requirements.
Responsible for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus.
Effective coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.
Generate quality metrics, trackers, and reports for management and clients to characterize the health of the client relationship and state of quality systems
TECHNICAL
Provide QA Technical recommendations based on trend analysis to eliminate future problems.
Participates in Product Development/Validation/Engineering project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements.
Reviews and approves technical documents, such as, but not limited to:
Technical Services Protocols and Reports;
Process Validation Protocols and Reports
Cleaning Validation Protocols and Reports
IQ/OQ/PQ Protocols and Reports;
MERs and material Specifications;
Product specifications;
Test methods;
Master Batch Records; and
Master Shipper Labels.
Change Control, as it pertains to the above validated/qualified systems and controlled documents
Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).
Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production.
COMPLIANCE
Provide support to internal, client, and regulatory audits.
Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times.
Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities.
IV. Knowledge Requirements:
Education or Equivalent:
Bachelors Degree in Science (Chemistry, Microbiology or Biology preferred) required or equivalent;
A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.
Prior experience working with validation, manufacturing or product development preferred. Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 101 2725 Scherer Drive North 13-4268760 St. Petersburg FL 33716 United States Education: Additional Job Details:
The Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control
The QA Product Manager for VMS (Vitamins Minerals and Supplements) products provides customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent St. Petersburg's customers and internal organizations. This position serves as a representative for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change controls and associated Master documents, including but not limited to MERs and material Specifications; Product specifications; Test methods; Master Batch Records; Master Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance and Calibration work order requirements for critical systems.
CUSTOMER FOCUS
Primary quality liaison for clients and internal customers. Is expected to become the Subject Matter Expert for the client products, processes and requirements.
Responsible for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus.
Effective coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.
Generate quality metrics, trackers, and reports for management and clients to characterize the health of the client relationship and state of quality systems
TECHNICAL
Provide QA Technical recommendations based on trend analysis to eliminate future problems.
Participates in Product Development/Validation/Engineering project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements.
Reviews and approves technical documents, such as, but not limited to:
Technical Services Protocols and Reports;
Process Validation Protocols and Reports
Cleaning Validation Protocols and Reports
IQ/OQ/PQ Protocols and Reports;
MERs and material Specifications;
Product specifications;
Test methods;
Master Batch Records; and
Master Shipper Labels.
Change Control, as it pertains to the above validated/qualified systems and controlled documents
Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).
Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production.
COMPLIANCE
Provide support to internal, client, and regulatory audits.
Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times.
Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities.
IV. Knowledge Requirements:
Education or Equivalent:
Bachelors Degree in Science (Chemistry, Microbiology or Biology preferred) required or equivalent;
A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.
Prior experience working with validation, manufacturing or product development preferred. Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 101 2725 Scherer Drive North 13-4268760 St. Petersburg FL 33716 United States Education: Additional Job Details:
