Note: The job is a remote job and is open to candidates in USA. Validation & Engineering Group, Inc. provides services and solutions to pharmaceutical, biotechnology, chemical, food, and medical device industries. The Investigation Writer III provides quality assurance support for a manufacturing plant by leading investigations, managing corrective and preventive actions, coordinating change plans, supporting complaint and product quality reviews, and ensuring cGMP and policy compliance.
Responsibilities
- Perform exception reports, complaints, PQRs, CP coordination and trend monitoring systems, assuring they are in compliance with Operations policies, plant procedures and regulations
- Investigate activities when an exception event occurs in the manufacturing, incoming laboratory, Quality Control laboratory, validation, microbiology, stability or complaints area
- Responsible for consistent and thorough exception events investigation, documentation and timely resolution of exception documents based on CAPA requirements
- Perform complaint investigations when product quality complaints are received at the plant and assuring, they are in compliance with Operations policies, plant procedures and regulatory requirements
- Perform laboratory investigations when out of specification or trend results are reported in accordance with procedures and policies
- Provide support to the plant users on the Expectation Events IT Systems
- Document and coordinate Local change plans assessment and strategies in support with the end user and functional impacted areas
- Perform periodic quality metrics related to investigations, complaints, CP, PQRs and other key performance indicators from areas of responsibility as requested by area managements
- Responsible of providing New Product support as a QA investigator writer as required by the New Product process and serve as a QA liaison between Third-Party Manufacturers or Third-Party Contractors
- Responsible of providing support during internal or external inspections
- Responsible for executing assigned tasks as required by the operational area
- Could be assigned the responsibility of evaluating potential events, as first point of contact, in the manufacturing floor, to define immediate mitigation activities
- Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process
- Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties
- Responsible of performing investigation activities when an exception event occurs in the manufacturing, incoming lab, validation, microbiology, stability, or complaints area
- Responsible for consistent and thorough exception events investigation, documentation and timely resolution of exception documents based on CAPA requirements
- Responsible of monitoring and continuous improvements of the CAPA quality system
- Compile the information and write the exception documents for multiple approvals
- Assure that exception documents are written according Operations policies, procedures and regulatory requirements
- Manage the exception event investigation process to assure all aspects of the exception event are investigated and root cause is determined
- Asses product impact, conduct through analysis and make informed and accurate recommendations of the implication of the exception event
- Determine appropriate corrective actions intended to correct the situation and prevent reoccurrence
- Assure exception events reports are approved on time as required by polices and regulatory requirements
- Assure al CAPAs determined through the investigation process are implemented on time in compliance with policies and regulatory requirements
- Assess CAPAs effectiveness in compliance with policies and regulatory requirements
- Responsible of performing complaints investigations when product quality complaints are received at the plant and assuring they are in compliance with Operations policies, procedures and regulatory requirements
- Assure complaint investigations are performed in a timely manner and appropriate actions are taken to protect the company and customer interests
- Implement any required CAPA
- Responsible of providing support to the plant users on the Exception Events IT System
- Responsible of maintaining the Product Quality Reviews (PQRs) system in compliance with policies, plant procedures and regulatory requirements
- Generate the PQRs for each product list number manufactured at the plant on a timely manner and assuring they are in compliance with regulatory regulations and requirements
- B. Prepare and approve PQR schedule as required assuring all products are included
- Perform statistical analysis and generate Trend Reports for each product requirement to be included in the PQR, as required
- Evaluate product performance based on the data collected for the PQR generation, such as change control, exception events, analytical, in process tests, stability, validation, regulatory, recalls, etc
- Determine any adverse trend or pattern that could lead to the change in specifications, manufacturing or control procedures. Perform Track and Trend of investigations to identify quality issues trend and perform monthly investigations metrics
- Perform periodic quality metrics related to investigations, complaints, PQRs and other key performance indicators from areas of responsibility as requested by area managements
- Responsible of providing NPI support as a QA investigator writer as required by the NPI process and serve as a QA liaison between Third Party Manufacturers or Third Party contractors
- Responsible of providing support during internal or external inspections
- Responsible for executing assigned tasks as required by the operational area
- Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process
Skills
- Bachelors Degree in Science or Engineering, preferably Biology or Chemistry with a minimum of four (4) years of experience in a Quality or technical field within the Pharmaceutical or Biotechnological industry
- Masters Degree in Science or Engineering, preferably Biology or Chemistry with a minimum of two (2) years of experience in a Quality or technical field within the Pharmaceutical or Biotechnological industry
- Advance knowledge and prior exposure in technical and operations necessary to successfully perform responsibilities of position. Knowledge of GMP, safety regulations
- Prior experience in CAPA, including authoring and approval of laboratory and manufacturing investigations. Experience in other quality system (example: Change management, risk management documentation) is desired
- Strong interpersonal and communication skills
- Strong problem-solving skills
- Capable of handling multiple priorities
- Five (5) years of experience within the Pharmaceutical Operations, preferably solid dose manufacturing process
- Effective verbal and written communication skills in both English and Spanish
Company Overview