Team Member - LCM

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)

1. 1. 1. Change request – 600+
      2. Variations – 80+
      3. 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