All-In-One Scriptless Test Automation Solution!
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 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.
a. Responsible for consistent and thorough exception events investigation, documentation and timely resolution of exception documents based on CAPA requirements.
b. Responsible of monitoring and continuous improvements of the CAPA quality system.
c. Compile the information and write the exception documents for multiple approvals.
d. Assure that exception documents are written according Operations policies, APL procedures and regulatory requirements.
e. Manage the exception event investigation process to assure all aspects of the exception event are investigated and root cause is determined.
f. Asses product impact, conduct through analysis and make informed and accurate recommendations of the implication of the exception event.
g. Determine appropriate corrective actions intended to correct the situation and prevent reoccurrence.
h. Assure exception events reports are approved on time as required by polices and regulatory requirements.
i. Assure al CAPAs determined through the investigation process are implemented on time in compliance with policies and regulatory requirements.
j. 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, APL procedures and regulatory requirements.
a. Assure complaint investigations are performed in a timely manner and appropriate actions are taken to protect the company and customer interests.
b. 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.
a. 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.
b. Prepare and approve PQR schedule as required assuring all APL products are included.
c. Perform statistical analysis and generate Trend Reports for each product requirement to be included in the PQR, as required.
d. 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.
e. 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:
• Bachelor degree, preferably in Engineering or Science.
List the minimum experience needed to qualify. Please include the position titles or descriptions of experience and required years.
• Experience within the Pharmaceutical Operations, preferably solid dose manufacturing process.
• Effective verbal and written communication skills in both English and Spanish.
Candidates MUST have experience in Manufacturing Process and Investigations