Job Description Summary

Responsible accountable as a lead for compliance.

To review and approval of all master document like standard operating procedures, batch manufacturing, incidents/events, process validation, annual product reviews, master datas, protocols and qualification documents.

To review the Production planning, weekly / monthly / yearly as per the forecast /market requirement and complete within timelines.

Utilization of resources as per the work demand and target timelines.

Effective coordination with CFT teams for smooth flow of Manufacturing and Packaging activities.

Responsible for QMS compliance investigation of event , market complaint effective CAPA closer.

Responsible for change control approval, execution and closure cycle.

Provide motivation, support and guidance to the team to build a quality working culture.

Job Description

Safety:

To ensure 100% safe operation in production area. Ensure all the necessary PPE’s are available in production facility and monitor proper PPE’s are worn by the personnel’s during operation. Reporting the near misses and ensure their compliance. To follow the procedure pertaining to the environmental management system (ISO14001 ISO45001). To support in implementation new procedure related to environment management system. To follow and maintain 5S in workplace.

Quality and Compliance:

No Critical/Major observations in GMP regulatory audit i.e. internal/external. cGMP compliance in entire manufacturing and packaging area and SOP compliance on all aspects. Upgradation of system consistently to deliver the quality production, improvement to plan. Ensure all area logbooks, BMR entries and all documents calibration records area online and updated. Area up keeping hygiene, cleanliness, all areas are in good condition for 24x7. Ensure proper people, material, scrap, SFG movement to avoid cross contamination. Ensure proper Status labeling of each area, item, equipment, accessories, and scrap movement. Ensure proper gowning in the production area, PPE, Personal hygiene. Ensure review and acknowledgement of the EMS alarm, power failure, tooling etc., To ensure 100% adherence to the SOP/Batch instructions, specifications, and control parameters. Follow ALCOA++ and ready for ant time inspection. To ensure Zero overdue on training assigned.

Head count and manpower handling:

People to follow shifts. Only required head count to plan. 100% utilization of head count. Share a trusting relationship with the work group. Provide motivation, support and guidance to the team to build a quality working culture.

Facility/Area management:

Check production facility building carvings, corners, ceiling, walls, wall guard etc., Ensure each and every item to be placed in its designated area with proper labelling. Developing down line people so that work should not get affect. Focus on continuous improvements on all means (Safety, quality, and delivery). Monthly reviews to perform Quality, yield, simplification, documentation, QMS, and take proper action.

Teamwork and Coaching

Ensure efficient collaboration and co-ordination with cross functional departments. Coach team members to solve increasing problems. Mentor team/subordinates in developing documentation. Regulatory interacts with senior management on matters concerning several functional areas, divisions and or customers. Work team COOSST to work efficiently. Involve on culture of excellence implementation and activities.

Key Responsibilities:

Responsible accountable as a lead for compliance. To review and approval of all master document like standard operating procedures, batch manufacturing, incidents/events, process validation, annual product reviews, master datas, protocols and qualification documents. To review the Production planning, weekly / monthly / yearly as per the forecast /market requirement and complete within timelines. Utilization of resources as per the work demand and target timelines. Effective coordination with CFT teams for smooth flow of Manufacturing and Packaging activities. Responsible for QMS compliance investigation of event , market complaint effective CAPA closer. Responsible for change control approval, execution and closure cycle. Provide motivation, support and guidance to the team to build a quality working culture. Regularly to interact with senior management on packaging improvisations and continuous improvement projects. Timely issue resolution through daily/weekly meetings. Day today interactions with the team and building up the co-ordination and effective communications. Troubleshooting the projects with assessment and handling continuous improvement project. Developing a systematic and smooth working environment for the team. Involve on culture of excellence implementation and activities. Review and approval of all master document like standard operating procedures, batch packing, events, process validation, qualification documents and other quality documents. Supporting to the Cross functional team during Audit. Site responsible for SAP training and control on the system. Ensure the Process capability studies and Risk Assessment. Responsible for continuous improvement projects.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.