Job requires supervising and managing all functions of Quality Assurance in API and pharmaceutical intermediate manufacturing to strictly make sure plant is following cGMP as per regulated market.
Supervising and education of staff in GMP.
Manage all employees in QA department and ensure its performance.
Overviewing finished product analysis data and releasing finished product.
Performing all tasks required by QA such as making BMR's, SOP's, Change control system, Deviations, Market complaints, Annual review reports, Validations, Qualifications, Vendor Audits, Trainings, Preparing other Documentation for example Site Master File & Validation Master Plan, QMS Implementation etc.
Candidate will also be responsible for facing Regulatory Audits from customers and authorities from regulated markets and be able to effectively communi
- Team development through coaching and mentoring
Build positive work environment
Manage team workload and performance
Planning timelines for work deliverables and delivering them on time with quality and accuracy
Managing team projects
- Excellent technical writing in English and editorial review and oral communication skills absolutely required.
Excellent problem solving and auditing skills are required.
Must be able to communicate effectively with customers and third parties and diverse audiences at all levels of an organization.
Must be a solid independent thinker with demonstrated ability to discern multiple viewpoints. Ability to complete work assignments and achieve results on time and within budget.
Must have proven ability to raise and resolve issues when others are directly accountable for outcomes. Demonstrated ability to build strong, credible working relationships across an organization.
Must have sound working knowledge various GMP and GLP standards, familiarity and exposure with internal audits, external GMP audits required.