- Complaints, Deviations, change controls, laboratory and operations related items and standard operating procedure changes
- Consultation must meet current regulatory requirements and be appropriate for the business.
- Provide critical support during regulatory agency and customer audits
- Guidance is practical and provided in time to be actionable.
- Interpretation of regulatory requirements is communicated in a way that is easily understood by the receiver.
- Consultation meets current regulatory requirements and is appropriate for the business.
- Assist/lead and close investigations the required time.
- Ensure investigations are conducted according to the severity defined in the SOP and support the investigation team throughout the investigation. Propose CAPA if needed and ensure any identified CAPAs are implemented.
- Participate to the recurrences analysis to define and deploy the appropriate CAPA
- Review and release the commercial batches according to the schedule, including MFT batches needed to support sterile products.
- Lead and complete complaint investigations.
- Serve as the main contact for customers including attending routine meetings.
- Review and challenge the quality agreement before approval by the quality managers.
- To BOM updates, equipment recipe updates, batch cards changes, and other documents linked to your scope, required for the above changes.
- Products meet customer needs and regulatory requirements and do not result in recalls.
- No recalls or audit observations associated with released product
- Ensures standard operating procedures and processes meet current industry requirements and are efficient for the business.
- Ensures CAPAs address root cause and reduce recurrence rates.
- Reviews and approves documentation such as procedures, protocols, reports as required by regulations.
- Ensures Change Controls are thorough and meet industry requirements.
- Provides support during customer and regulatory inspections.
- Ensures Quality Metrics are delivered.
- Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies.
- Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
- Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
- Written Communication: Can write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.
- Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.
- Bachelor's Degree in Chemistry, Biology, Pharmacy, or related field.
- Minimum of 2-5 years' experience in FDA regulated environment, preferably in a pharmaceutical manufacturing setting.
- QA/compliance experience in manufacturing, facility operation, laboratory compliance and quality system.
- Experience in audits and regulatory inspections (FDA & others).
Customer Quality Specialist II - Rochester, United States - Visron Technical
Description
Details:
Our client is a world leading contract development and manufacturing organization of pharmaceutical products. Located in France, the USA, Brazil, and China, we provide comprehensive innovation & development services to fulfil every aspect of contract pharmaceutical manufacturing needs.
The Customer Quality Specialist conducts and supports problem investigations (deviations), change controls and customer complaints in accordance with company procedures and current regulatory requirements, for sterile and non-sterile products. For complaints this includes managing the receipt, processing and monitoring of each complaint and providing the completed investigation to the customer within the required timeframe.
The Customer Quality Specialist completes review of laboratory data and completes final release of finished products. This position will serve as a frequent inter-organizational contact and will represent the QA department on teams for the Customers. This role is responsible for review and approve a wide variety of GMP related documents and provide appropriate feedback when necessary.
This position interacts with manager and director levels of management in all departments in developing solutions and providing timely and accurate communication. As a Customer Quality Specialist, frequent interactions will occur with our customers including documentation approvals, deviations, change controls and various meetings and business reviews. The Customer Quality Specialist will serve as the main QA contact for customers regarding deviations, Change Controls, complaints, and any other quality concerns.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Quality System Guidance & Advice (30%)
Provides Quality Assurance consultation which may include: