CAREERS
QA Manager
Position : QA Manager
Experience : 08-10 Years
Job Description:
The purpose of this role is to oversee and support the overall Quality and Compliance activities during the product development, manufacturing and life cycle processes.
Responsibilities:
In addition, to ensure Plant and R&D activities are in compliance with regulations.
- Support Plant and R&D Product Development team & plant in Quality & Compliance.
- Support & ensure Health Authority, Local regulatory & Quality systems are met with Plant and R&D team.
- Support Plant and R&D and provide assistance in project / technology / method transfer to commercial QA/QC.
- Implement, train & maintain GMP/GLP Quality Manual in Plant and R&D (FD & AD).
- Author, implement, train, periodic review of Plant and R&D SOPs.
- Review and approve CMC and non CMC related documents, including product specification, batch documentation, test method, analytical validation report, method transfer, equipment qualification and cali-bration related documents, process validation protocol and reports and packaging documentation.
- Review & approve batch records, packaging records, CoAs, stability data, expiry dating etc.
- Support clinical supplies / pilot batches activities, including providing formal approval and release for clinical supplies / pilot batches and registration samples.
- Manage QA systems such as Change Control, Planned / Unplanned Deviation, Lab investigations, and CAPAs for Plant and R&D (FD & AD).
- Perform cGMP audit of internal Plant and R&D facilities and operations as well as 3rd Party vendors and follow up with corrective action.
- Support Heath Authorities audits evaluate and follow up on the appropriateness and completeness of corrective action plans until closure.
- Participate in development of GMP training program, on job documentation training for Plant and R&D personnel and provide on-going GMP training to the Plant and R&D associates.
- Prepare Quality Agreement with new 3rd party / contract labs as required by the development team.
- Perform routine GMP rounds / visits to the laboratory & manufacturing area, ensure compliance, perform line clearance, review batch records online, perform AQL checks, in-process checks,
- Prepare technical reports.
- Provide monthly KPIs and status reports on projects and compliance initiatives to management.
- Perform other duties as required or necessary
Preferred Education/Qualifications: Minimum Bachelor / Master of Science in Pharmacy.
Experience:
- At least 8 – 10 years’ experience in the pharmaceutical industry in Plant and R&D QA role.
- Experience in new facility setup & commissioning.
- Competent in training associates, innovate new systems, develop GMP culture for an organisation.
- QA and cGMP experience in Pharmaceutical, GMP and regulatory (GxPs) requirements including auditing and inspection against regulatory / quality standards.
- Demonstrated experience in managing multiple projects and deadlines.
- Good communication, planning, and organization skills.
- In depth understanding of pharmaceutical manufacturing, regulatory constraints, validation and product development.
- 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.
- Team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity and communication. Must be adaptable to a diversified working environment.