Company: Renaissance Pharmaceuticals
Posted on: August 2, 2019
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
--- Execute QA duties as stipulated in CFR 21 Part 58 Section
--- 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
--- 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
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
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
Good knowledge of computer systems, i.e. Microsoft, Word, Excel &
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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