Quality Assurance Inspector - Epping at Aspen Pharma Group

Description

• Fine Chemicals requires the services of a highly competent and experienced QA Inspector for the Quality Assurance Department.  To qualify for this position the most suitable candidate must fulfill the following requirements.

Requirements
JOB REQUIREMENTS:

• A tertiary qualification - National Diploma/BTech in Quality or BSc Chemistry or Life Sciences
• GMP experience – knowledge of ICH and FDA guidelines for API manufacturers and their application, and relevant Quality system certification
• Must be computer literate, MS Windows, i.e., Word, Excel, PowerPoint, etc.
• Validation, Regulatory, and Production experience will be advantageous

BASIC JOB FUNCTIONS (Brief Summary):

• Carrying out site audits
• Document/report writing, reviewing, issuing, and change control
• Preparing the site for external audits and Regulatory Inspections
• Verification of validation activities within the nominated manufacturing area
• Producing and checking labels for raw materials, intermediates, and finished goods according to the set standard operating procedures and master schedule of standard labels
• Checking the issuing of tamper-evident packaging components according to the set procedure
• Ensuring production complies with cGMP, the BPR instructions, and all related SOPs
• Reviewing BPRs and raising deviations where necessary
• Assisting with the batch release procedure
• Maintaining the electronic databases related to the batches released
• Maintaining relevant filing systems that ensure traceability of the position’s functions
• Investigating and documenting deviations
• Participating in root cause analysis and CAPA identification
• Understanding and complying with all relevant SOPs
• Facilitate training in compliance with cGMP
• Performing internal audits
• Collate data as required to support the successful execution of validation studies
• Consult with Procurement and QC on Raw Material related matters to ensure BOM requirements are met, and Compliance issues attained (approval of suppliers)
• Provide ad hoc support to NPD Tech Transfer projects, legacy product re-location and validation
• Participate and review Risk Assessments as required
• Perform QA review of Regulatory statements/declarations

PERSONAL ATTRIBUTES (Brief Summary):

• Observation – ability to observe and evaluate processes and proceduresExcellent organisational and administrative skills
• Excellent problem-solving skills
• Attention to detail – proofreading and auditing
• Ability to communicate with all levels of the business
• Ability to interpret regulations and take initiative
• Confident to address adverse issues at all levels of the business
• Good interpersonal skills
• Ability to apply critical thinking to arising situations/scenarios