JOB Description
Department: Quality Assurance
Position: Sr. Manager / Head
Job Role:
- Preparation review of departmental Standard Operating procedure, Work Instructions and forms.
- Provide training to personnel on SOPs, work Institution, forms GMP and GDP compliance.
- Perform review and organize the qualification activities for the contract manufacturing organization, contract Testing Laboratory as per regulatory requirements to ensure GMP and GDP compliance.
- Monitoring and reporting on the effectiveness of the Quality management system within the organizations and at outsourced service providers.
- Initiation and Review of change control, Deviation and complaints as per requirement.
- Responsible for closing the QMS actions.
- Circulating and monitoring the QMS Dashboard activities.
- Review quality technical agreements with outsourced service providers.
- Assist the Qualified Auditors in performing audits at service providers facility.
- Monitor performance and help identity improvement and effectiveness of the Quality activities.
- Perform, review and organize supplier qualification activities for the Active Pharmaceutical Ingredients, excipients and packaging materials as per regulatory requirements to ensure GMP and GDP compliance.
- Creating, performing the software validation activities and related documentation.
- To carry out the assignments assigned by the Director and management.
- Manage and maintain an effective Quality Assurance program for the organisation in alignment with Global Operating Procedures.
- Ensure Vendor qualifications done at CMO/In-house.
- Discussion with CMO regarding compliance issues.
- Review operating procedures to ensure compliance with all related procedures, instructions and the Quality Manual.
- Provide guidance to the team in the development, implementation, monitoring and review of QA procedures.
- Establish procedures and methods to comply with applicable EU GMP & USFDA, ISO requirements and customer expectations.
- Ensures timely resolution to customer inquiries.
- Review customer requirements and make sure the system is in place to meet them.
- Investigate and ensure implementation of the corrective actions associated with non-conformances, including, customer audits and complaint reports with CMO.
- Drive continuous quality improvement projects at plant based on site data and customer expectations.
- Drive compliance to global harmonization initiatives.
- Assure proper use of change management associated with validated processes.
- Co-ordination with CMO & discuss the quality related issues in PV & routine commercial batches manufacturing.
- Review's data, analyses result and recommends changes based upon findings and performs follow up to verify effectiveness in PV & routine commercial batches manufacturing.
- Drive continuous quality improvement projects and global harmonization initiatives.
- Maintain clear communication paths with stakeholders.
- Identifies and determines quality improvement.
- Maintain clear communication paths with stakeholders.
- Performs other duties as assigned based on business needs.
- Co-ordinate Internal Stakeholders to move the processes in smooth manner.
Basic Qualifications:
- Education: M. Pharma/ M.Sc
- Experience: 8-15 years of experience in Quality Assurance / Quality System
Preferred Knowledge, Skills and Abilities:
- Superior organizational and leadership skills with ability to help team grow and thrive
- Experience with Customer interface and meeting customer expectations.
- Demonstrate team building and problem-solving skills
- Ability to effectively prioritize and escalate issues
- Working familiarity with Project Management
- Able to comply with the company's quality policy at all times
Company Website- https://www.novumgen.com/
