Senior Manager 2 - Compliance & Internal Audits

As the Senior Manager - Compliance and Internal Audit at Sun Pharma, Mohali, you will be responsible for overseeing the compliance and internal audit functions at the site. Your primary role will involve ensuring the site's readiness through internal audits, preparing for regulatory agency audits and inspections, and implementing corrective actions based on observations made by agencies or internal audit teams. You will also be tasked with monitoring and tracking quality assurance/control metrics across site manufacturing and other cross functions. Your key areas of responsibility will include monitoring all cGMP activities at the site, supporting regulatory inspection management, tracking compliance actions resulting from audits, preparing timely inspection responses, collaborating with Corporate compliance group for global CAPA implementation, overseeing cross functional investigation teams, and reporting the compliance status of the site to the Site Quality Head regularly. You will play a critical role in supporting major health authority inspections, approving investigation plans, conducting self-inspections (internal audits), and leading internal quality audit teams to ensure compliance with SUN Pharma's internal standards and cGXP requirements. Additionally, you will be responsible for maintaining audit schedules, audit logs, and audit closure reports, as well as collaborating with corporate audit groups for site audits. Your role will also involve educating and promoting a culture of quality and compliance at the site, reviewing audit observations and deciding compliance strategies, and verifying compliance status of previous audit observations in subsequent audits. You will be expected to interact with various internal departments, as well as external stakeholders such as Corporate & Cluster Quality, Consultants, and Regulatory/Customer Inspectors. To qualify for this position, you should hold a minimum of M. Sc. / M. Pharma or B Pharma degree, along with an Auditor Certification. Ideal candidates will possess at least 15 years of experience in auditing, investigation, and data integrity. This role requires individuals who are detail-oriented, analytical, and have strong communication and leadership skills. Please note that this job description provides a general overview of the responsibilities and qualifications associated with the role of Senior Manager - Compliance and Internal Audit. The employer reserves the right to modify these duties as needed based on the incumbent's experience and background.,