The Company – Syner-G Pharma Consulting, LLC:
- A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls
(CMC) and Quality Assurance for biopharmaceutical companies (small molecule and biologic products).
- Adept in developing risk-based CMC strategies in accordance with cGMP for 21st Century initiatives and Quality by Design (QbD) principles.
- Distinguish ourselves by our passion for creativity and innovation.
- Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios.
- Clients include national and multinational pharmaceutical companies.
Syner-G Pharma Consulting is seeking a talented QA Manager, Batch Release with a BS/MS in science, chemistry, biology, or engineering. The QA Manager will provide the support to Batch Release program for Syner-G clients. The QA Manager is responsible for preparing, reviewing, and managing batch related documents from pre-clinical development through commercialization of pharmaceutical and Biologics. They will work on supporting daily quality assurance operations through the process of reviewing batch records as well as associated quality documents and releasing the batches for US market for the Syner-G Pharma clients. Additionally, they will also assist with reviewing and managing Syner-G internal QA activities and documents.
Critical success factors:
- Business owner (point of contact) and subject matter expert for Batch Release.
- Reviews and approves batch related documentation and records in cooperation with QS management.
- Provide Batch release support to Client Quality Operations.
- Performs internal document and record audits.
- Manages periodic review process.
- Bachelor’s degree in life sciences or a technical discipline.
- Minimum of 5-7 years’ experience required in working in Quality Assurance.
- Knowledge of regulatory guidance’s and industry standards for QA Product Release area.
- 5-7+ Years of Experience working with paper and EDMS (Electronic Document Management System)
- Experience in Preparing, reviewing, and editing cGMP batch records, CMC regulatory, and Quality documents.
- Presents solid understanding of quality assurance concepts and practices.
- Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.
- Strong organizational, analytical, and problem-solving skills (e.g. tracking and managing multiple documents).
- Excellent written, verbal, and interpersonal skills.
- Strong orientation for quality and customer services.
Able to work independently with moderate supervision, including ability to escalate appropriately.