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Form of workJob Description
Description/Comment: ONSITE - DURATION 6 MONTHS - SHIFT - MON - FRI 8AM-5PM OR 9AM - 6PM.
EXP - INVESTIGATION WRITING (CUSTOMER COMPLAINTS PHARMA DRUGS) & ANNUAL PRODUCT REVIEW - TREND ANALYSIS, DATA (EXCEL & MINITAB) & CHANGE CONTROL MANAGEMENT (PRODUCT, PROCESS, AND FACILITY CHANGES FOCUS.
II. Basic Function:
This position is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints; preparing annual product reviews, tracking and trending, and follow-up of the Change Control and CAPA programs. This position interacts directly with manufacturing, engineering, product development, technical services, validation, etc personnel and is responsible for the quality/regulatory feedback loop to those impacted areas. Also, this position will involve preparing filings to support site registrations and permits as well as regulatory submissions to the FDA, FL DBPR, and other worldwide agencies as needed to support Customer filings under the direction of the Supervisor. In support of this activity, this position will review change control notifications of all types to determine impact on regulatory filings. Furthermore, this position will participate in the internal audit program.
III. Specific Activities, and Responsibilities:
" Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required
" Prepare and submit all federal, state and local permits in timely manner
" Interact with Customers and gather information as needed to support registration activities
" Provide regulatory impact assessment on all change controls as required
" Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation under direction of the Group Leader
" Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution
" Prepare APRs in accordance with site procedures and timelines.
" Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
" Assess product complaints and APR trends, provide guidance and collaborate on plans of action to address trends as per site SOPs.
" May author other types of quality system documents as directed or assigned by QA management.
" Liaise with customers to ensure customer requirements are satisfied.
" Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure
" Author/compile monthly, quarterly and annual summaries and metrics
" Other duties as required in support of Catalent Pharma Solutions high performance, such as but not limited to, assisting site management in driving and enforcing cGMPs; mentoring other individuals within the organization in compliance; participating in Internal Assessments; facilitating routine compliance and CAPA Review Board meetings, including follow up actions; facilitating and conducting training.
Education or Equivalent:
" Bachelor's Degree in Science or related field required (Chemistry, Microbiology or Biology);
" A minimum of 3 years related experience in the pharmaceutical manufacturing industry. 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:
EXP - INVESTIGATION WRITING (CUSTOMER COMPLAINTS PHARMA DRUGS) & ANNUAL PRODUCT REVIEW - TREND ANALYSIS, DATA (EXCEL & MINITAB) & CHANGE CONTROL MANAGEMENT (PRODUCT, PROCESS, AND FACILITY CHANGES FOCUS.
II. Basic Function:
This position is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints; preparing annual product reviews, tracking and trending, and follow-up of the Change Control and CAPA programs. This position interacts directly with manufacturing, engineering, product development, technical services, validation, etc personnel and is responsible for the quality/regulatory feedback loop to those impacted areas. Also, this position will involve preparing filings to support site registrations and permits as well as regulatory submissions to the FDA, FL DBPR, and other worldwide agencies as needed to support Customer filings under the direction of the Supervisor. In support of this activity, this position will review change control notifications of all types to determine impact on regulatory filings. Furthermore, this position will participate in the internal audit program.
III. Specific Activities, and Responsibilities:
" Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required
" Prepare and submit all federal, state and local permits in timely manner
" Interact with Customers and gather information as needed to support registration activities
" Provide regulatory impact assessment on all change controls as required
" Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation under direction of the Group Leader
" Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution
" Prepare APRs in accordance with site procedures and timelines.
" Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
" Assess product complaints and APR trends, provide guidance and collaborate on plans of action to address trends as per site SOPs.
" May author other types of quality system documents as directed or assigned by QA management.
" Liaise with customers to ensure customer requirements are satisfied.
" Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure
" Author/compile monthly, quarterly and annual summaries and metrics
" Other duties as required in support of Catalent Pharma Solutions high performance, such as but not limited to, assisting site management in driving and enforcing cGMPs; mentoring other individuals within the organization in compliance; participating in Internal Assessments; facilitating routine compliance and CAPA Review Board meetings, including follow up actions; facilitating and conducting training.
Education or Equivalent:
" Bachelor's Degree in Science or related field required (Chemistry, Microbiology or Biology);
" A minimum of 3 years related experience in the pharmaceutical manufacturing industry. 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:
