Easter Seals Jobs

JobDescription

DESIGNATION : Compliance and Internal Audit Head

Job Grade : DGM

Job Location : Mohali

RESPONSIBILITY:

• Lead site internal, corporate, external, customer and regulatory inspections and responses.

• Facilitate support to ensure achievement of accountabilities for team members of compliance group at site.

• Lead compliance team at site to ensure overall compliance to Sun Pharma standards and cGxP requirements at site.

• Facilitate review and support regulatory inspection management.

• Lead the support team for major health authority inspections at site and provide input & support to inspection responses to drive consistency and clarity at the site.

• Facilitate and ensure timely preparation of inspection response and monitor implementation of various compliance actions / CAPA arises due to regulatory inspections and internal\customer audits.

• Collaborate with corporate compliance group and site team and resolve issues in implementing global CAPA.

• Review Global CAPA issued, internally communicate and ensure effective implementation of global CAPA.

• Facilitate, review and monitor cross functional investigation teams.

• Regularly evaluate and report compliance status of site to Site Quality Head / Quality Cluster Head.

• Responsible for approval of investigation plan to proceed for critical investigations.

• Support compliance investigations as needed in collaboration with others at the site.

• Provide support in execution and monitoring of remediation compliance through compliance verification audits.

• Responsible for all compliance and bringing solutions to compliance related issues within the site.

• Review regulatory inspection observations, trend and decide compliance strategy.

• Educate and institutionalize a culture of Quality and compliance at the site.

• Responsible for on time Health Authority notifications, Field alert report and Recall management.

• Responsible for self-inspection (Internal Audits) management at site and to ensure self-inspection of all quality systems & sub systems are performed at the site in accordance with established SOPs & SUN Pharma global quality policy / standards.

• Responsible to perform internal audit as per site specific procedures.

• Perform all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements

Education : B.Pharm / M.Pharm

Experience : 17 to 20 Yrs (with regulatory experience in OSD)

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.