Audit & Compliance Senior Specialist
- Sanofi India Ltd
- 2 - 5 years
- Ahmedabad
- 5 years ago
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Job Description
Mission Statements
- Support the Audit and Compliance lead and QMS manager in ensuring the continuous site readiness for inspection.
- To perform the Internal site audit as Qualified Auditor.
- Coordinate the implementation of quality systems in accordance with GxP and the Group guidelines and ensure their application on site through:
- Management tools (ITS systems and SOPs)
- Self - inspections
- Vendor/Supplier qualification
- Ensure compliance through APR and group policy evaluation.
- Coordinate inspection preparation program
- Support global quality organization for third party audit
Duties & Responsibilities:
- Responsible for the Planning, Execution, Documentation of Supplier, Distributors & Service provider s audits.
- Handling & Execution of Quality Third Parties (QTP) / Supplier Management Activities.
- Responsible for the Preparation of the list of Approved Suppliers / Vendors.
- Evaluation of Suppliers/Service Providers form and Supplier Pre - Audit Questionnaires.
- To Perform Supplier annual performance review (SAPR).
- Preparation / Establishment of Quality Agreement (QTA) with Supplier / Vendor.
- Coordination with Sanofi global team for global vendors (Supplier & Service providers) qualification etc.
- To Perform and Initiation of auditor qualification as per procedure.
- Handling of Deviation / CAPA / Change Control related to Self - Inspection, Supplier and Sub - contractors.
- Responsible for the follow up of Corrective and Preventive action plan of the vendor based on the vendor audits.
- Handling of supplier complaints.
- Preparation of the Event/CAPA trending.
- Handling of Market compliant/Product complaint and participate in its Investigations.
- Responsible for the Preparation of Self - Inspections schedule & Self - Inspection execution as per the schedule.
- Responsible for the timely closure of self - inspection observations and its reports.
- Participation, Coordination and support during Regulatory inspections.
- Responsible for the Execution of the Inspection Readiness tool before any Regulatory Inspection.
- Adhere to HSE policies and procedures.
- To Perform other responsibilities delegated by Department Head as per requirement.
Knowledge, Skills & Competencies / Language
- Strong business knowledge in Quality Systems with strong technical knowledge of GMP requirements associated with Pharmaceutical Production (Facilities, equipment, production processes).
- Knowledge of the manufacturing sites, and the requirements of their external regulators.
- Sound understanding of manufacturing environment and typical equipment and systems.
- Ability to work with supply chain operation and planning team.
- Able to maintain a high degree of professionalism when dealing with Supplier / Third Party.
- Knowledge of GMP audits.
- Lead Competencies:
- Act for Change: Embrace change and innovation and initiate new and improved ways of working.
- Cooperate Transversely: Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results.
- Develop People: Take responsibility for developing one's self.
- An excellent verbal and written communication skill in English is required.
Qualifications
- A minimum of Bachelor s Degree in Pharmacy or life sciences or equivalent experience is required.
- A minimum of 6 plus years of relevant work experience in various dosage forms. Experience in Injectable Pharmaceuticals is a plus.
- Exposure to domestic and international GMP regulatory inspections or audit is a plus.
Requirements of the job
- This position requires a minimum travel within and outside of India as per business requirement.
- In depth knowledge of various regulatory body requirement.
- This position will suit an individual who is able to operate with discretion and confidentiality about sensitive data.
- Easy to adopt and learn new and advance quality systems.
- This position requires to adopt well to new and advance quality systems.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Accounts, Finance, Tax, Company Secretary, Audit,
Role Category: Finance/Audit
Role: Finance/Audit
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any SpecializationPost Graduation: Post Graduation Not Required
Doctorate: Any Doctorate in Any Specialization, Doctorate Not Required
Contact Details:
Company: Sanofi IndiaLocation(s): Ahmedabad
Keyskills: Supply chain Quality systems Pharmacy Diversity and Inclusion Inspection Life sciences HSE GMP QTP Auditing
Sanofi India Ltd
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the...
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