Freshers Pharma Team Member Post Vacancy @ Cipla

Freshers Pharma Team Member Post Vacancy @ Cipla

Freshers Pharma Team Member. Cipla Ltd invites postgraduate M.Pharma undergraduate B.Pharma candidates for the post of Team Member. post vacancy at Cipla Ltd. Candidates looking for Pharmaceutical Science jobs can grab this opportunity of working with Cipla Ltd. Check out all the details

Job Title: TEAM MEMBER FDA CO-ORDINATION/ RESEARCH

Educational qualifications: B.Sc./ B.Pharm / Communication / Agency / PR firm.

Relevant experience: 2-3 years of experience

Salary: INR 1,75,000 – 3,00,000 PA.

Job Purpose:

1. Checking product labels/ artwork of all Cipla products as per the labelling requirements of Indian rules, to ensure compliance with regulatory requirements

2. Preparing applications for Test license NOC, Export NOC, Additional product approval, COPP & WHO-GMP approvals

Accountabilities:

• Accountability Cluster & Major Activities / Tasks
• Timely approval of Copy matter checklist (CMCL) of product labels. (Local & Export market)
• Issue FDA product license to packaging dept which is required to upload in CMCL system
  Check product label as per labelling rules (D&C Act) and provide final sigh off to print artworks after clearance from CQA dept)
  Schedule Confirmation: Confirmation of respective Products w.r.t. its schedule G / H / H1.
• Verifying product label artworks offline through email for confirmation of labelling matter (3rd party locations)
• Check product label with labelling rules
• Preparing and submission of FDA license applications for additional products, Test license NOC, Export NOC, COPP & WHO-GMP approvals
• Collect required documents from internal stakeholders
• Compile license application in the format as prescribed by the respective authority for submission
• Provide product license, Mfg. License, neutral code license or test license to internal
• stakeholder as per the requirements for new or additional products. Providing available license copy to internal stakeholders by the same day.
• Everyday follow-up with plant location for draft license & product license on a regular basis.

Dimensions:

1. On an average 15-20 drug license applications
2. 400-600 CMCL- artwork approvals monthly
3. Research work/Regulatory/Policy

Key Decisions:

• Decisions
• Implementing regulatory changes or up-gradation effectively on product label
  Make & arrange to submit FDA applications to the respective Licensing authorities in the desired format of respective state / central drug department.
• Recommendations
• Resolving any technical queries raised by respective stakeholders in consultation with
• Reporting manager as and when required.

How  To Apply:

Interested candidates can mail their resume on [email protected]

Regards,
Catherine Coelho
Human Resources
Cipla Pharmaceuticals Ltd

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