Team Member - LCM

Cipla

  • South Africa
  • Permanent
  • Full-time
  • 23 days ago
  • Apply easily
DivisionDepartmentSub Department 1Job PurposeImplement 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 trackingSave the relevant data after closure of change control, submission of re-registration dossier, annual report, requalification and variation package to regional RAKey Accountabilities (6/6)Major ChallengesInadequate documentation to evaluate change request, variations causing rework. Overcome by preparing a checklist document of necessary documentation to be shared with whosesoever raises the CRKey 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 variationKey Decisions (2/2)Education QualificationMinimum Graduate in Pharmacy or Life Sciences.Relevant Work ExperienceMinimum 2 years in the field of Regulatory Affairs/ Quality Assurance/ Quality control/ Manufacturing/ Analytical Development/ R&D

Cipla