NAG Compport Testing-1

Dr Reddy's Laboratories Ltd - Sandbox; Princeton (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A global pharmaceutical company is seeking a Quality Oversight Specialist in Princeton, NJ, who will be responsible for ensuring compliance with quality standards and conducting investigations for product quality complaints. The candidate must possess a Bachelor’s degree in a relevant science and have over 5 years of experience in a Pharmaceutical Quality role. Strong attention to detail and excellent interpersonal skills are essential for this position, along with experience in root cause analysis and proficiency in SAP. This position may require working occasional overtime.

Qualifications

• 5+ years of experience in a Pharmaceutical Quality/Product Disposition role.
• Proficient with computer skills and SAP experience.
• Ability to work with strict timelines and changing priorities.

Responsibilities

• Conduct root cause investigations for product quality complaints.
• Ensure compliance with cGMP, FDA regulations and ICH guidelines.
• Assist in stability program management.

Skills

Attention to detail

Interpersonal skills

Root cause analysis tools

Computer skills

Statistical applications

Ability to work independently

Education

Bachelor’s degree in a science related to pharmaceuticals

Tools

SAP

Job description

At Dr. Reddy’s, a global pharmaceutical company, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

Job Description

Purpose: To administer supportin collaborating with Quality, Manufacturing, Packaging, Technical Services, and Engineering teams to provide quality oversight of new equipment, systems, and process validation. This position will also assess changes to existing equipment and processes in a pharmaceutical manufacturingDRL Shreveport Plant.

Key Requirements/Skills

• Bachelor’s degree in a science related to the manufacture and testing of pharmaceutical products with experience in an in-process quality role is required.
• 3 – 5 years of experience in a Pharmaceutical Quality role/Product Disposition.
• Must have attention to detail and insistence on correctness and completeness as an element of all decisions.
• Ability to work with strict timelines and changing priorities.
• Requires strong interpersonal skills that support working in a team environment.
• Ability to work with others and without direct supervision.
• Good written, oral, organization and interpersonal skills.
• Experience and knowledge with root cause analysis tools.
• Proficient with computer skills, statistical applications and SAP experience is preferred.
• Must be able to work occasional overtime and shifts per the needs of the business.
• Conduct and document in accordance with SOPs root cause investigations of routine customer product quality complaints.
• With Manager of Quality performs and documents in accordance with SOPs root cause deviation investigations of non-complex issues.
• Assists in analyzing data for trends and present data in monthly quality reviews.
• Assist in the collection and summarization of data for annual product reviews or other purposes.
• Assist in stability program management for study initiation, sampling and compilation of data.
• Works with peer departments in managing CAPAs.
• Conducts internal audits of operations and quality to ensure compliance with cGMP, FDA regulations and ICH guidelines
• Assist with corporate quality team for vendor audits and qualification
• Provides quality oversight for day shift manufacturing floor operations in absence of first shift quality personnel.
• Any other duties as assigned by manger.

Job Duties And Responsibilities:

• Conducts and documents root cause investigationsfor customer product quality complaints in accordance with industry guidance(s) andSOPs.
• Conducts internal auditsto ensure compliance with cGMP, FDA regulations and ICH guidelines.
• Assists in the collection and summarization of data for annual product reviews or other purposes.
• Assists with corporate quality team for vendor audits and qualification.
• Assists in analyzing stabilitydata.
• Provides operations and laboratory systems oversight.
• Assists with stability program management as needed.
• a) Initiation of stability studies
• b) Stability sample pulls

Qualifications

Key Personnel Attributes & Qualifications

• Bachelor’s degree in a science related to the manufacture and testing of pharmaceutical products.
• 5+ years of experience in a Pharmaceutical Quality/Product Disposition role.
• Possess a working knowledge of and has demonstrated successful application of quality management system elements.
• Must have attention to detail and insistence on correctness and completeness as an element of all decisions.
• Ability to work with strict timelines and changing priorities.
• Requires strong interpersonal skills that support working in a team environment.
• Ability to work with others and without direct supervision.
• Good written, oral, organization and interpersonal skills.
• Experience and knowledge with root cause analysis tools.
• Proficient with computer skills, statistical applications and SAP experience is preferred.
• Must be able to work occasional overtime and shifts per the needs of the business.

Additional Information

All your information will be kept confidential according to EEO guidelines.