▷ (High Salary) Team Member - LCM
3 days ago
Job Description Division Department Sub Department 1 Job Purpose Implement Life cycle management activities for Non-respi products (for US, EU, South Africa, ANZ, WHO, PEPFAR & 150+ countries ) to have Business continuity. Key Accountabilities (1/6) Assess change request across the globe allocated by GL to review, evaluate and categorize the change as per regulatory guidelines to meet launches, commercial needs and compliance - Determine applicability of change and coordinate with units, Quality Assurance, change initiators, regional teams to get appropriate documents to assess changes. - Track the change request allocated and compile the final evaluation including regional comments through system Key Accountabilities (2/6) Prepare variation packages for modules 2 to 5 and deficiency response across the globe to support commercial launches, on-going commercial and regulatory compliance. - Coordinate with units, regional teams, QA, API-RA, purchase, R&D, ADL to ensure appropriate documents availability. - Compile variation packages as per priorities assigned. - Compile response to deficiencies on variations. Key Accountabilities (3/6) Prepare annual report (US) as per schedule to meet regulatory compliance for business continuity. Prepare WHO requalification dossier to maintain product licence for business continuity - Assess the previous submitted annual report/ requalification. - Coordinate with units, regional teams, QA, API-RA, purchase, R&D, ADL to get appropriate documents to compile Annual report and requalification dossier. - Compile the annual report and requalification dossier as per schedule and make corrections as per suggestions/instructions from group leader. Key Accountabilities (4/6) Compile re-registration dossier to maintain product licence for business continuity. - Assess previous submitted dossier for re-registration. - Coordinate with units, regional teams, CDT, QA, API-RA, purchase, R&D, ADL to get appropriate documents. - Compile the reregistration dossier & make corrections as per suggestions/instructions from group leader. - Update relevant tracker. Key Accountabilities (5/6) Maintain and update product database for easy retrieval and status tracking Save the relevant data after closure of change control, submission of re-registration dossier, annual report, requalification and variation package to regional RA Key Accountabilities (6/6) Major Challenges Inadequate documentation to evaluate change request, variations causing rework. Overcome by preparing a checklist document of necessary documentation to be shared with whosesoever raises the CR Key Interactions (1/2) - Manufacturing unit for documentation (Daily) - Clinical department for documentation (As per need) - Purchase department for supporting documents (As per need) - ADL and R&D (As per need) - CPM (As per need) - CQA (2-3 times per week) - Packaging (As per need) Key Interactions (2/2) - API supplier (As per need) Dimensions (1/2) Handling LCM related activities for non-repi products across globe (for US, EU, South Africa, ANZ, WHO, PEPFAR & 150+ international countries) - Change request 600+ - Variations 80+ - Renewals 80+ Annual reports/re-qualification 10+ Dimensions (2/2) Key Decisions (1/2) Rejection/ approval of change controls and categorisation of variation Key Decisions (2/2) Education Qualification Minimum Graduate in Pharmacy or Life Sciences. Relevant Work Experience Minimum 2 years in the field of Regulatory Affairs/ Quality Assurance/ Quality control/ Manufacturing/ Analytical Development/ R&D
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