Quality Assurance and Regulatory Consultant (Pharmaceutical) || Paramus, NJ(Hybrid) || - IT MINDS L.L.C.

Quality Assurance and Regulatory Consultant (Pharmaceutical)

Location: Paramus, NJ(Hybrid)

Long Term

Job Type:
Contract (Project-Based)

Experience in solid dose Pharmaceutical manufacturing and packaging (bottle filling). A Quality background would be a plus. Must have background in Pharmaceutical manufacturing and packaging. Preferable Bulk Manufacturing & Packaging.

Project Overview:
We are looking for a highly experienced Quality Assurance and Regulatory Consultant to assist with a critical analysis and process improvement project. The consultant will investigate two key issues related to customer complaints: "low-fill" bottles and "broken tablets" in packaging. This role will involve a thorough review of the complaints, as well as the packaging and manufacturing processes, with the goal of identifying root causes and recommending improvements.

Key Responsibilities:

• Analyze customer complaints regarding "low-fill" bottles and "broken tablets."

• Review packaging processes to identify causes of "low-fill" counts, particularly focusing on 200mg / 30ct bottles, which have shown an increase in complaints since late 2022.

• Examine the manufacturing process related to "broken tablets," an issue that has been prevalent since mid-2023.

• Provide detailed recommendations for improving both the packaging and manufacturing processes to reduce these complaints.

• Suggest potential improvements in the packaging process that could help filter out broken tablets before they are bottled.

• Develop a comprehensive report summarizing findings and recommended process improvements.

Key Qualifications:

• Proven experience in quality assurance and regulatory compliance within the pharmaceutical or related industries.

• Expertise in reviewing and optimizing manufacturing and packaging processes.

• Strong analytical skills, with the ability to identify root causes and propose actionable solutions.

• Experience handling customer complaints and regulatory concerns, particularly related to product quality.

• Strong written and verbal communication skills to present findings and recommendations clearly.

Skills:

• Knowledge of pharmaceutical packaging and manufacturing standards.

• Familiarity with industry regulations and best practices for quality control.

• Ability to work independently and manage timelines efficiently.

karthik@itminds.net