Tracks and reports all regulatory activities for the India business, ensuring timely RA action
Local maintenance of India specific / site specific licenses for product
Trading / Imported products creates or compiles documentation and coordinates communications for all RA activities of the local site with respect to interaction and liaison with the RA units abroad.
Export To own parent company abroad: creates or compiles documentation and coordinates communications with parent company abroad unit for all RA activities of the local site with respect to interaction and liaison of India products being sold for export
Export Other Countries: creates or compiles documentation and coordinates communications for all RA activities of the local site with respect to interaction and liaison of India products being sold for export to other countries.
Responsible for creating and/or maintaining India regulatory files related to products made in India for India. This includes new product registrations or site specific manufacturing registration changes as well as updates or re-formulations as may be required.
Liaison to RA consultant or support services when required
Responsible to ensure artwork/labeling, PI and promotional materials used in India are compliant.
Accountable for Quality Management System
Oversees the activities conducted under the QMS including the electronic document management system
Oversees Quality Assurance and Quality Control staff
Responsible to assess product for correct disposition
Responsible to review and assess and authorize Change Control Requests, product and materials specifications, SOPs and deviation investigations
Manages the performance and development of all direct reports. In conjunction with the Human Resources Department and the Director of QA, conducts Employee Relations activities (such as: completion of employee performance reviews, carrying out performance improvement initiatives and guiding employee improvement action plans, recommend and administer disciplinary action, and guide conflict resolution by investigating employee complaints and initiating suitable resolution).
Conducts the hiring process for departmental staff.
Allocates QA and Documentation resources according to the requirements of the work schedule and monitor job performance to ensure that assignments are completed in a timely and efficient manner.
In absence of the Director of Quality Compliance, acts with full authority and decision-making capacity for all QA decisions.
Oversees the QA batch record review process and determination of batch status (i.e. release, rejection, or product hold for further clarification or investigation). Assess potential impact of incidents and processing non-conformances on the quality and suitability of the product for sale.
Ensures that all Quality Systems are managed in an effective manner in accordance with SOPs and that quality investigations are closed in a timely manner.
Participates in the supplier qualification and external auditing program.
Leads and/or provide technical expertise for quality investigations (DIR, OOS, and ECS) to ensure product impact is assessed, root cause is identified and corrective/preventative action(s) are implemented.
Participates in inter-departmental discussions and teams to represent the quality department interests and subsequently serve as a communication conduit to collect / distribute related information. In addition, co-ordinate applicable activities of the quality department as appropriate.
Provides support to validation and technical study activities including the review and approval of data / documentation.
Supports Regulatory Affairs activities as required, as related to obtaining / preparation of documentation required for related filings.
Support clinical studies as required (i.e. auditing).
Attends all major regulatory inspections (e.g. US FDA, Health Canada) is a requirement for this position.
Acts as an ambassador in modeling and promoting a safe work environment. Is accountable for the enforcement and monitoring of the Safety Program and holds managers accountable for enforcing safety rules / regulations.
Leads, directs, evaluates, and develops a team in accordance with the companies Mission, Vision and Values Statements, policies, and current standard business practices
Performs other related duties as required