Team Lead Auditor

Purpose of the Role

Audit Role:-To Analyse & decide Risk based audit plans guide the team on preparation & finalization of Internal Audit Execution process monitor & review the audits have robust follow up process work on simplification of the sustainable solutions.

Operating Network:

Internal Stakeholders:

MC CEO COO BU Head & Teams Global Quality Management Manufacturing Teams (CTO / FTO Plants) Plant Quality Teams SCM Team (Planning & inventory management Logistics Procurement Strategic sourcing External manufacturing Capacity management) IPDO Teams Maintenance Capital projects management Administration Safety IT teams and Assurance leaders ERM Compliance Country and sub-function Quality Heads.

External Stakeholders: Audit Committee Consultants

Reports to: Group Lead Internal Audit

Location: Banjara Hills Hyderabad

Qualifications :

Experience & Requirements

10 years of experience in Pharma industry in quality function out of which at least 5- 6 years is in leadership role managing teams.

1. Minimum 3 years of experience in any one of the following:
a. Quality Assurance
b. Regulatory Compliance
2. Experience developing and implementing audit strategies and schedules for GMP compliance is mandatory.
3. Exposure to conducting high-level risk assessments and identifying potential areas of non-compliance within manufacturing processes including handling of active pharmaceutical ingredients (APIs) sterile production and packaging is preferred.
4. Experience interpreting and applying GMP regulations from agencies such as the FDA EMA and WHO and ensuring alignment with company policies and procedures is desired.

5. Thorough knowledge of SOPS GMP GLP GDP ALCOA Principles is mandatory.

Qualifications:

Bachelors Degree in Life Sciences Pharmacy Chemistry or a related field is mandatory. Postgraduate degree in Quality Management Pharmaceutical Sciences or a related field is preferred.
Certifications such as Certified GMP Professional (CGP) Certified Quality Auditor (CQA) or equivalent are preferred.

Roles & Responsibilities:

Risk Based Annual Audit Plan

To Prepare for a Risk Based Annual Audit Plan considering following factors:

o Universe of all plants locations and processes

o Risk assessment of each process

o Previous audit results in the audit area

o Emerging risks including top risks identified under ERM

o Key changes in people systems organization structure strategy

o Inputs from AC and management on key risks and concerns

o Fraud risk and proactive reviews for fraud detection

To Assist in deciding coverage through process reviews continuous monitoring and prioritization based on risk assessment and other relevant factors in order to arrive at an Audit Plan which has a comprehensive coverage and is dynamic to emerging risks

Delivery & Completion of Audits as per Annual Audit Plan

Ensure completion of audits as per the approved audit plan and provide guidance & supervision to the team during execution.

Monitor the engagement progress (including outsourced) ensuring quality and timeliness in execution appropriate management action plans based on the root cause analysis and severity of the issues and discussing & communicating the results to senior levels management to improve the efficiency and effectiveness of the processes and achievement of the business objectives.

Post Audit Follow up

To monitor the implementation of the audit recommendations and agreed action plans as per their due dates through periodic reviews with the team ensuring proper documentation of the action taken before closure of the open items and escalation of deviations / delays through monthly MIS to senior management and quarterly reporting to Audit Committee.

Management and Audit Committee Reporting

Support the CAE and Group Lead in preparing presentations to the Audit committee and for Management reporting.

Engage with the key stakeholders to increase the visibility of the audit function and add value to the organisation.

People Management

Conduct goal setting performance appraisals and mentoring/coaching for own team members; collaborate with HR in manpower planning recruitment activities and identifying training needs of team members.

Stakeholders Management

Stakeholder management involves identifying and engaging with parties who have an interest in or are affected by the audit being conducted. Effective stakeholder management requires understanding their needs expectations and potential influence to ensure a successful outcome. To proactively manage Stakeholders expectations handling conflicts in a mature manner and develop communication plan that can address stakeholders queries.

Knowledge Management  

To Identify training needs for the development of the team conducting knowledge sharing sessions participating in the seminars & conferences relating to quality and Internal Audit.

To Conduct session/presentation on relevant topics within the team. Enhance employee awareness of quality function by conducting internal awareness session with audited and key stakeholders taking up relevant certification to ensure development of self and team members to ensure continuous learning improvement in efficiency and implementation of best practices

Additional Information :

About the Department

Global Manufacturing Organisation (GMO)
At Dr. Reddys Laboratories we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence we are a leading force in the pharmaceutical industry.

We operate 19 state-of-the-art manufacturing plants across Hyderabad Vizag Baddi Mexico Shreveport and Mirfield comprising 8 OSD facilities 3 Injectables facilities and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1150 drug master files across key therapy areas such as Oncology Cardio-vascular Central Nervous System and Anti-Diabetes. The World Economic Forum has recognised our largest manufacturing facility in Bachupally Hyderabad as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive meeting business imperatives and meeting our ambitious ESG goals. Building such factories of the future is integral to innovation and to build healthcare of the future.

Benefits Offered

At Dr. Reddys we actively help to catalyze your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions...

For more details please visit our career website at Work :

No

Employment Type :

Full-time