compliance associate

summary hyderabad, telangana a client of randstad india permanent reference number JPC - 77347 job details Job Description Job Title* Associate Global Regulatory AffairsCompliance Dept. R&D / Central RALine Manager Job Title* Senior Global Manager Regulatory Affairs Compliance Job Purpose* This role provides operational support for the implementation within Global Regulatory Affairs of the ... Internal Control Framework (ICF) elements such as risk assessment, written standards and control, training, management monitoring (MM) and responding to problem (CAPA/CC/deviation management) also supporting regulatory community in internal audits (Independent Business Monitoring (IBM), Independent Assurance/A&A) or external inspections. Within Global Regulatory Affairs, this role is responsible for assigned activities e.g. ensuring written processes and procedures (e.g. SOPs, WIs, etc) are in place with associated training, internal audits(MM) are timely performed, CAPA/deviation/change control related to processes are completed on- time and relevant KPIs are deployed aligning with Enterprise policies and supporting the overallcompliance and risk assessment in the Global Regulatory Affairs Oversight Committee (GROC). This role may support relevant internal audits or external inspections that impact the Global Regulatory team and drive on-time completion of the related CAPAs. This role supports oversight and awareness of local internal/external regulatory audits to ensure learnings are captured and processes/systems updated in line with CAPAs/recommendations. Key Responsibilities (10 bullet points maximum) Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role Support risk assessment ensuring regulatory strategic risks related to process are identified, managed and mitigated/prevented. Support the SOP/Process Committee and/or support/participate in relevant networks (QMS, RD) to ensure development and maintenance of written processes and procedures (e.g. SOPs, WIs, etc) within Global Regulatory Affairs, aligned with Enterprise Policies. Manage training associated to global processes and procedures (e.g. SOPs, WIs, etc) in Global and Regional Regulatory Affairs from dispatch to reporting in the relevant Learning System. Carry out assigned internal assessment (Management Monitoring) of Global Regulatory Affairs as agreed with Regulatory Management. Identify and escalate opportunities for improvement in Regulatory and Enterprise-wide. Generate metrics that promote the value of compliance and, that support the generation, interpretation and drive of continuous compliance improvement programs for Global Regulatory Affairs. Provide relevant metrics and data into the Global Regulatory Affairs Oversight Committee (GROC) to support overall compliance and risk assessment. May support during relevant internal audits and external inspections that impact Global Regulatory Affairs (with links to the Quality organization).GSK QD-REC-128561 v: 1.0 Retrieved: 22 Oct 2022 Approved: 02 Jun 2022R&D Central RA Job Description - Compliance AssociateApprovedProprietary Information. Do not disclose without consent. The current version from Veeva QualityDocs must be used. Page 1 of 4.Breadth/ Scope of Accountability* Provide details of any scope data relevant to the role e.g. the net sales that the role supports / generates or budget responsibility.Number of Direct Reports None Number of Indirect Reports NoneAnnual Budget managed by this role (Provide either Revenue/ Assets Managed or Operating budget) Annual Direct Revenue Accountability (please add currency) NA Assets Managed, if applicable (please add currency) NA Operating Budget Accountability, if applicable (please add currency) NAKnowledge/ Education / Previous Experience Required* A. Educational Background List any academic or practical education that must be obtained to be qualified to perform this role. 1. Minimum Level of Education* Life Science degree (or equivalent) Area of Specialisation* Life science, Regulatory Affairs, Quality Assurance, Pharmacy Why is this Level of Education Required? Ensures basic level of scientific/regulatory understanding 2. Preferred Level of Education Area of Specialisation Why is this Level of Education Preferred? B. Job-Related Experience Describe what experience this position will require the job holder to have obtained in past roles within or outside of the company that would demonstrate a level of proficiency in the stated role.Minimum Level of Job- Related Experiencerequired• 1-3 years' experience in a Regulatory Affairs/Quality area 1-3 years within consumer healthcare or pharmaceutical companyWhy is this Level of Experience Required?Governance and compliance are critical to business sustainment and company's reputation – lack of compliance with internal or external standards can have severe consequences to the business hence the role requires a level of experience.C. Other Job-Related Skills/Background List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job. IT SkillsWritten and Verbal skillsMandatory field GSK QD-REC-128561 v: 1.0 Retrieved: 22 Oct 2022 Approved: 02 Jun 2022R&D Central RA Job Description - Compliance AssociateApprovedProprietary Information. Do not disclose without consent. The current version from Veeva QualityDocs must be used. Page 2 of 4.For Departmental use Authors / Approvals Job Description Completed by (relevant GRALT member):Reg. Governance & Operations Lead Date: May 2022Role Description Reviewed Line Manager Printed Name and Signature: Date:**By signing this job description, employee acknowledges: His/her role as per details defined previouslythat his/her electronic signature as used in a validated electronic system is the legal equivalent of handwritten signature and understand that it is forbidden to share or reveal private information which would allow someone else to execute an electronic signature under his/her identity. Employee** Printed Name,Initiales,MUDID, and Signature1 1 if appropriate in accordance with local legal and HR guidance (consult RA Compliance in case of doubt)Date:GSK QD-REC-128561 v: 1.0 Retrieved: 22 Oct 2022 Approved: 02 Jun 2022R&D Central RA Job Description - Compliance AssociateApprovedProprietary Information. Do not disclose without consent. The current version from Veeva QualityDocs must be used. Page 3 of 4.R&D Central RA Job Description - Compliance Associate Document Approvals by Electronic SignatureVerdict: Approve Carole Burnier Pichlyk cb575783 (carole.a.burnier-pichlyk@gskch.com) Author Approval 20-May-2022 14:00:54 GMT+0000 Verdict: Approve Claudine Scolaro cs885236 (claudine.x.scolaro@gskch.com) Regulatory Compliance Approval 20-May-2022 14:29:05 GMT+0000 Verdict: Approve Sven Van Gyseghem sv781473 (sven.x.van-gyseghem@gskch.com) Management Approval 02-Jun-2022 11:35:17 GMT+0000 show more Job Description Job Title* Associate Global Regulatory AffairsCompliance Dept. R&D / Central RALine Manager Job Title* Senior Global Manager Regulatory Affairs Compliance Job Purpose* This role provides operational support for the implementation within Global Regulatory Affairs of the Internal Control Framework (ICF) elements such as risk assessment, written standards and control, training, management monitoring (MM) and responding to problem (CAPA/CC/deviation management) also supporting regulatory community in internal audits (Independent Business Monitoring (IBM), Independent Assurance/A&A) or external inspections. Within Global Regulatory Affairs, this role is responsible for assigned activities e.g. ensuring written processes and procedures (e.g. SOPs, WIs, etc) are in place with associated training, internal audits(MM) are timely performed, CAPA/deviation/change control related to processes are completed on- time and relevant KPIs are deployed aligning with Enterprise policies and supporting the overallcompliance and risk assessment in the Global Regulatory Affairs Oversight Committee (GROC). ... This role may support relevant internal audits or external inspections that impact the Global Regulatory team and drive on-time completion of the related CAPAs. This role supports oversight and awareness of local internal/external regulatory audits to ensure learnings are captured and processes/systems updated in line with CAPAs/recommendations. Key Responsibilities (10 bullet points maximum) Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role Support risk assessment ensuring regulatory strategic risks related to process are identified, managed and mitigated/prevented. Support the SOP/Process Committee and/or support/participate in relevant networks (QMS, RD) to ensure development and maintenance of written processes and procedures (e.g. SOPs, WIs, etc) within Global Regulatory Affairs, aligned with Enterprise Policies. Manage training associated to global processes and procedures (e.g. SOPs, WIs, etc) in Global and Regional Regulatory Affairs from dispatch to reporting in the relevant Learning System. Carry out assigned internal assessment (Management Monitoring) of Global Regulatory Affairs as agreed with Regulatory Management. Identify and escalate opportunities for improvement in Regulatory and Enterprise-wide. Generate metrics that promote the value of compliance and, that support the generation, interpretation and drive of continuous compliance improvement programs for Global Regulatory Affairs. Provide relevant metrics and data into the Global Regulatory Affairs Oversight Committee (GROC) to support overall compliance and risk assessment. May support during relevant internal audits and external inspections that impact Global Regulatory Affairs (with links to the Quality organization).GSK QD-REC-128561 v: 1.0 Retrieved: 22 Oct 2022 Approved: 02 Jun 2022R&D Central RA Job Description - Compliance AssociateApprovedProprietary Information. Do not disclose without consent. The current version from Veeva QualityDocs must be used. Page 1 of 4.Breadth/ Scope of Accountability* Provide details of any scope data relevant to the role e.g. the net sales that the role supports / generates or budget responsibility.Number of Direct Reports None Number of Indirect Reports NoneAnnual Budget managed by this role (Provide either Revenue/ Assets Managed or Operating budget) Annual Direct Revenue Accountability (please add currency) NA Assets Managed, if applicable (please add currency) NA Operating Budget Accountability, if applicable (please add currency) NAKnowledge/ Education / Previous Experience Required* A. Educational Background List any academic or practical education that must be obtained to be qualified to perform this role. 1. Minimum Level of Education* Life Science degree (or equivalent) Area of Specialisation* Life science, Regulatory Affairs, Quality Assurance, Pharmacy Why is this Level of Education Required? Ensures basic level of scientific/regulatory understanding 2. Preferred Level of Education Area of Specialisation Why is this Level of Education Preferred? B. Job-Related Experience Describe what experience this position will require the job holder to have obtained in past roles within or outside of the company that would demonstrate a level of proficiency in the stated role.Minimum Level of Job- Related Experiencerequired• 1-3 years' experience in a Regulatory Affairs/Quality area 1-3 years within consumer healthcare or pharmaceutical companyWhy is this Level of Experience Required?Governance and compliance are critical to business sustainment and company's reputation – lack of compliance with internal or external standards can have severe consequences to the business hence the role requires a level of experience.C. Other Job-Related Skills/Background List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job. IT SkillsWritten and Verbal skillsMandatory field GSK QD-REC-128561 v: 1.0 Retrieved: 22 Oct 2022 Approved: 02 Jun 2022R&D Central RA Job Description - Compliance AssociateApprovedProprietary Information. Do not disclose without consent. The current version from Veeva QualityDocs must be used. Page 2 of 4.For Departmental use Authors / Approvals Job Description Completed by (relevant GRALT member):Reg. Governance & Operations Lead Date: May 2022Role Description Reviewed Line Manager Printed Name and Signature: Date:**By signing this job description, employee acknowledges: His/her role as per details defined previouslythat his/her electronic signature as used in a validated electronic system is the legal equivalent of handwritten signature and understand that it is forbidden to share or reveal private information which would allow someone else to execute an electronic signature under his/her identity. Employee** Printed Name,Initiales,MUDID, and Signature1 1 if appropriate in accordance with local legal and HR guidance (consult RA Compliance in case of doubt)Date:GSK QD-REC-128561 v: 1.0 Retrieved: 22 Oct 2022 Approved: 02 Jun 2022R&D Central RA Job Description - Compliance AssociateApprovedProprietary Information. Do not disclose without consent. The current version from Veeva QualityDocs must be used. Page 3 of 4.R&D Central RA Job Description - Compliance Associate Document Approvals by Electronic SignatureVerdict: Approve Carole Burnier Pichlyk cb575783 (carole.a.burnier-pichlyk@gskch.com) Author Approval 20-May-2022 14:00:54 GMT+0000 Verdict: Approve Claudine Scolaro cs885236 (claudine.x.scolaro@gskch.com) Regulatory Compliance Approval 20-May-2022 14:29:05 GMT+0000 Verdict: Approve Sven Van Gyseghem sv781473 (sven.x.van-gyseghem@gskch.com) Management Approval 02-Jun-2022 11:35:17 GMT+0000 show more experience 4