Senior Manager- Audit and Compliance

Job Description

Designation: Senior Manager- Audit and ComplianceJob Location: Bengaluru, IndiaDepartment: Continuous Improvement and Internal AuditAbout SyngeneSyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.The Role
• This role requires auditing for all computerized system across Syngene. The role will evaluate that all electronic records, electronic signatures, handwritten signatures executed to electronic records are trustworthy and reliable.
• The role will verify that all electronic records across all OUs of Syngene are generated, maintained, and archived as per current regulatory expectations and Syngene procedures.
• This role will also support the Head IQA & CI in implementation of various digitization initiatives complying to the Syngene established procedures.
Key Result AreasRole-specificQuality Audit/Digitization Management
• Carryout regular audit of various computer systems across Syngene and verification of GxP (GMP, GLP and GCP) systems with respect to 21 CFR Part 11, EU Annex 11, GAMP 5, WHO Annex 5, ISO 13485 guidelines with exposure on Data Integrity and Reliability controls and risk-based approach.
• Perform audits of validation and system documents, test scripts, codes where feasible.
• Evaluate risk and review computerized systems in QA, QC, IT and various other functions for data integrity gaps.
• Should have proficiency, knowledge, skills, tools and techniques for Project management to deliver digital solutions or cloud-based quality management system with integrated modules that work together to support quality, compliance and effective decision making. Ensure paperless QA and QC activities including implementation and sustenance of Electronic Lab Notebooks or equivalent recording and managing systems. Actively involved in initiating digitized processes in quality to minimize errors in the process and quality assurance activity due to human intervention.
• Collaborate with external partners in jointly managing and executing validation activities.
• Ensure Self Inspection Team are trained and qualified appropriately to conduct internal system audit.
• Ensure Horizontal deployment of learning across all verticals of Syngene as a part of harmonized IT compliance, related regulatory guidelines and industry best practices.
• Represent as SME for internal audit and digitization activity.
• Will be responsible for Computerized System Life Cycle Management (CSLCM) which includes conceptualization, assessment, evaluation, implementation, validation, operation and retirement stages of computerized system. With effective project management and problem-solving skills.
• Will handle IT-QA, Digital Transformation, Process Automations & Data Analytics (application /technology implementation /management, implementation of enterprise level IT solutions and data analysis using various tools and dashboards)
• Responsible for review of CAPA management for GxP systems of Syngene.
• Responsible to drive implementation and sustenance of various Operating Systems (OS) like TrackWise, EDMS, LMS, LIMS, ELN and any other enterprise systems that would be taken up as part of project execution.
• Support Head IQA & CI in budgeting activity (Capex and Opex) of new and existing GxP computerized system compliance enhancement projects.
Planning/Operational
• Prepare plan for audits and spot audits for compliance verification of GxP computerized systems across Syngene.
• Ensure GxP based system software licensing are adhered.
• Ensure additional Pre-Audit for gap assessment are conducted as deemed necessary before any Client audit or regulatory Inspection.
• Co-ordinate with IT for addition, modification, or development of computerized systems/software.
• Carry out due diligence for software deployment and effectiveness of software functioning.
• Execute and review of documents related to CSV for various digitization projects.
• Monitoring and providing inputs for e-enabling projects for QA and QC.
• Reviewing relevant procedures and protocols related to IT systems.
• Ensuring periodic upgradation of all e-systems are completed as per timelines in coordination with IT and IT QA team.
• Discuss all Non-Conformances with individual stakeholders and ensure availability of Corrective and Preventive actions with Timelines and responsibility and ensure all CAPA are verified and addressed as per committed timelines.
Safety & EHS
• Follow Environment, Occupational Health, Safety and Sustainability (EHSS)) requirements always in the workplace ensuring individual and laboratory/plant safety.
• Attend relevant training programs on Environment, Occupational Health, Safety and Sustainability (EHSS) measures imparted across the organization.
Education and Experience Education
• Strong educational pedigree and consistent academic track record.
• Graduate in Pharmacy / Master in Science with experience in Quality Assurance.
• Certification in Quality Audit skills.
• Experience and knowledge in Computer System Validation and GAMP 5 requirements.
Industry Experience
• 10 to 15 years of relevant post-education experience.
Technical/Functional Skills
• High-level English Proficiency in reading, writing and communication
• Able to work on own initiative and as part of a team. Proven leadership skills involving managing, developing and motivating teams to achieve their objectives and organization goals. First-class analytical, design and problem-solving skills. Dedicated to maintaining high quality standards. Excellent computer skills. Versatile to new tasks/skills quickly.
• In-depth knowledge of cGMP and regulatory requirements.
• Hands-on experience in handling project management tools.
• Thorough functional and technical knowledge various Pharma Industry related software with deployment, configuration, customization, user training, writing and executing the validations.
• Thorough understanding of electronic system compliance.
• Advanced proficiency in Microsoft applications including Microsoft Project, PowerPoint, Excel, Word and Outlook.
• Well-versed with quality audits and compliance verification activities.
Other competencies required for the role
• Excellent people skills with extensive experience in leading change and proven ability to instill a culture of collaboration.
• Strong customer and service delivery mindset with a proven track record in delivering quality projects.
• High degree of results orientation with a track record of growth and delivering against targets.
• Strong industry knowledge on quality and trend in latest cGMP requirements like GAMP 5, 21 CFR Part 11, EU Annex 11 and WHO Annex 5,
• Adequate knowledge on various health and regulatory requirements for ICH and other emerging markets.
• Ability to develop new ideas and creative solutions.
• Impeccable ethics and integrity, along with exposure to a multi-cultural work environment.
• Thorough knowledge of the various business processes involved in pharmaceutical industry.
Equal Opportunity EmployerIt is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
accountancyquality management systemelectronic lab notebookssalesfinance