Senior Investigation Writer

Description

Job Responsibilities:

• List all major responsibilities of the position in order of importance and priority to the overall job. Describe the outcome that must be produced in a accomplishing the job. Each supports the overall purpose of the job.
• Responsible of performing Exception Reports, Complaints, PQRs and Trend Monitoring systems, assuring they are in compliance with Client Operations policies, APL procedures and regulatory regulations and requirements.
• Primary Quality liaison between site quality and other areas of a plant operation such as MS&T, Supply Chain, Operations, Incoming Quality, Engineering, Third Party Manufacturers (TPM),Third Party Contractors(TPC), etc.
• 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 Client Operations policies, APL 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 Client polices and regulatory requirements.
• Assure al CAPAs determined through the investigation process are implemented on time in compliance with Client policies and regulatory requirements.
• Assess CAPAs effectiveness in compliance with Client 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 Client Operations policies, APL 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 Client policies, plant procedures and regulatory requirements.
• Generate the PQRs for each product list number manufactured at APL on a timely manner and assuring they are in compliance with regulatory regulations and requirements.
• Prepare and approve PQR schedule as required assuring all APL 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 APL and 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.

Knowledge/ Education Required:

• List the minimum education, skills, requirements, practical knowledge, etc., needed to qualify.
• Bachelor degree, preferably in Engineering or Science.
• Experience Required: List the minimum experience needed to qualify. Please include the position titles or descriptions of experience and required years.
• 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.

Job Description:

• Job Description Attached file
• Years of experience/education and/or certifications required: BS degree on science or Engineer and 5 years minimum experience Solid Dose Manufacturing experience CAPA full acknowledge and experience Candidates withour CAPA experience will not be considered

What are the top 3-5 skills requirements should this person have?

• Fully Bilingual candidate is required
• Solid Dose Manufacturing –
• Tablet Manufacturing experience
• Responsible for consistent and throuhgt exception events investigation, documentation and timely resolution of exception documents based on CAPA requirements, investigation manufacturing system, acknowledge with corrective and preventive actions
• Manufacturing Investigation Report Experience is REQUIRED.
• Candidate will be responsible of performing investigation activities when an exception event occurs in the manufacturing incoming lab, validation, microbiology, stability or complaints area.
• Advance Presentation/Leaderships Skills

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Problem Solving Certification
• CAPA Certification