IPQA-In process Quality Assurance
Job Description
Job Description
As the In-Line Quality Assurance you play a crucial role in ensuring the quality, safety, and compliance of pharmaceutical products throughout the manufacturing process. This position is responsible for performing inspections, monitoring processes, and conducting assessments to guarantee that products meet regulatory standards and internal quality requirements.
In-line Quality Inspection: Conduct real-time inspections of pharmaceutical products at different stages of the manufacturing process, including raw materials, intermediate products, and finished goods, to verify compliance with quality standards and specifications.
Quality Control: Perform physical, visual, and functional tests on pharmaceutical products using approved testing methods and equipment to ensure they meet required quality parameters.
Documentation: Accurately record inspection results and quality control data in designated forms or electronic systems, maintaining comprehensive documentation for review and audit purposes.
Deviation Detection: Identify and document any deviations, defects, or non-conformities during the production process, and report them to the appropriate personnel for investigation and resolution.
GMP Compliance: Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) while conducting inspections to ensure compliance with regulatory requirements and internal quality standards.
Equipment Verification: Ensure that inspection equipment is properly calibrated, validated, and maintained to guarantee accurate and reliable quality control measurements.
Communication: Collaborate with production personnel, supervisors, and quality assurance teams to communicate inspection findings, address quality concerns, and contribute to process improvement discussions.
Root Cause Analysis: Participate in root cause analysis activities to determine the underlying reasons for quality issues and assist in the implementation of corrective and preventive actions.
Batch Release: Support the batch release process by reviewing inspection data and providing input to ensure that the final products meet all quality specifications before release to the market.
Training: Assist in training production operators and other team members on quality standards, inspection techniques, and adherence to GMP guidelines.
Continuous Improvement: Suggest and implement process improvements that enhance product quality, efficiency, and safety on the production line.
Other duties as assigned.
Education:
High school diploma or equivalent. Additional education or training in pharmaceutical manufacturing, quality control, or a related field is desirable.
Experience:
2 years prior experience in quality control or inspection within the pharmaceutical or medical device industry is a plus.
Technical Knowledge:
Familiarity with Good Manufacturing Practices (GMP) and quality assurance principles.
Strong attention to detail and the ability to perform accurate and reliable inspections.
Basic understanding of pharmaceutical manufacturing processes and equipment.
Excellent written and verbal communication skills to document findings and communicate effectively with team members.
Ability to work independently and collaboratively in a fast-paced production environment.
Analytical and problem-solving skills to identify and address quality issues promptly. with the ability to collaborate and influence cross-functional teams.
Proven track record of driving continuous improvement initiatives and achieving quality objectives.
Organizational Skills:
Strong organizational skills are necessary to coordinate various aspects of the quality process to ensure efficiency and meet targets. Must have attention to detail.
Knowledge of Safety Regulations:
Must prioritize workplace safety and ensure compliance with safety regulations. Understanding and enforcing safety protocols is vital to maintain a safe working environment and prevent accidents or injuries.
Computer Skills:
Knowledge of quality systems as well as Microsoft Word & Excel.
Company DescriptionStrive Pharmaceuticals is a packaging supplier over-the-counter medications and Nutritional products. A cGMP facility that is fast paced and growing – offering personal and professional growth opportunities to employees.
Company Description
Strive Pharmaceuticals is a packaging supplier over-the-counter medications and Nutritional products. A cGMP facility that is fast paced and growing – offering personal and professional growth opportunities to employees.