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Manager, RDQA

Company: Renaissance Pharmaceuticals
Location: Lakewood
Posted on: August 2, 2019

Job Description:

Overview

Provide QA leadership for GMP product quality systems and activities from drug development to registration to launch for customer owned products in support of Renaissance Contract Development/Manufacturing. Additionally, the chosen individual will support efforts to resolve technical issues and complex investigations related to product non-conformances. This role will have responsibility for maintaining and strengthening the quality culture by supporting the implementation of quality management processes, tools, and principles as well quality by design across R&D.

Responsibilities

--- Execute QA duties as stipulated in CFR 21 Part 58 Section 58.35
--- Ensure that product quality requirements are met throughout all phases of the product life cycle
--- Maintain up-to-date knowledge of applicable regulations, guidance and standards and apply knowledge to the product development process
--- Provide QA leadership on new product initiatives and current business improvement projects
--- Train personnel on applicable GMP regulations and participate in development of GMP training program.
--- Review and approve R&D documents
--- Partner with colleagues across functions to build trust, inspire others and drive results.
--- Review and approve CMC and non-CMC related documents, including product specification, batch documentation, test method, analytical validation report, method transfer, equipment qualification and calibration related documents, process validation protocol and reports and packaging documentation.
--- Review & approve batch records, packaging records, CofAs, stability data, expiry dating etc.
--- Assist with technical issues and complex investigations related to product non-conformances.
--- Perform mock audits with the R&D team to ensure inspection ready status at all times
--- Assist in Authority inspections related to R&D questions that arise.

Qualifications

o Minimum Bachelor of Science in Chemistry
o At least 7 years Pharmaceutical experience in Research & Development, Quality or Regulatory systems.
o QA and cGMP experience in Pharmaceutical, GMP and regulatory (GxPs) requirements including auditing and inspection against regulatory / quality standards.
o Demonstrated experience in managing multiple projects and deadlines.
Good communication, planning, and organization skills.
o In depth understanding of pharmaceutical manufacturing, regulatory constraints, validation and product development.
o Excellent analytical, organizational, and problem-solving skills.
Good knowledge of computer systems, i.e. Microsoft, Word, Excel & PowerPoint.
Demonstrated understanding best pharmaceutical industry practices, cGMPs, and Quality Assurance and Regulatory.
o Team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity and communication. PI112393940

Keywords: Renaissance Pharmaceuticals, Lakewood , Manager, RDQA, Executive , Lakewood, New Jersey

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