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Cipla Life Sciences Job For Graduates, Apply Online For Team Member – LCM Post

Cipla Life Sciences Job For Graduates, Apply Online For Team Member – LCM Post. Life Sciences Graduate Apply Online at Cipla For Team Member – LCM Post. BSc life sciences job opening at Cipla. Interested and eligible applicants can check out all of the details on the same below

Job role: Team Member – LCM

Job ID: 76888

Job location: Vikhroli, Maharashtra, India

Division: IPD

Department: IPD

Employment Type: Permanent

About us:

At Cipla, we constantly work towards ensuring access to high quality and affordable medicines to support patients in need. Which is why, we have been trusted by health care professionals and patients across geographies for the last 8 decades.

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

Accountabilities

  1. 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
  2. Prepare variation packages for modules 2 to 5 and deficiency response across the globe to support commercial launches, on-going commercial and regulatory compliance.
  3. Prepare annual report (US) as per schedule to meet regulatory compliance for business continuity.
  4. Prepare WHO requalification dossier to maintain product licence for business continuity.
  5. Compile re-registration dossier to maintain product licence for business continuity.
  6. Maintain and update product database for easy retrieval and status tracking

Competencies/Skills

  • Communication Skills (clarity of thought, comprehension)
  • Likely potential for growth
  • Job / Product / Technical Knowledge / Pharma domain knowledge
  • Presentation & Interpersonal skills (If applicable)
  • Managerial or People Management skills
  • Safety awareness (If applicable)
  • Relevance of Previous Experience
  • Comprehension, Analytical & Problem solving abilities
  • Productivity & Result Orientation (If applicable)
  • Attitude
  • Qualification fitment
  • Sales drive (If applicable)
  • Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)

Education Qualification: Minimum Graduate in Pharmacy or Life Sciences

Relevant Work Experience: 5 years in the field of Regulatory Affairs/ Quality Assurance/ Quality control/ Manufacturing/ Analytical Development/ R&D

APPLY ONLINE

Here are a few interview questions with answers for the role of Team Member – LCM at Cipla:

1.Can you explain the key responsibilities of a Team Member – LCM and how they contribute to business continuity? Answer: As a Team Member – LCM, the key responsibilities involve implementing life cycle management activities for Non-respi products across multiple countries. This includes assessing change requests from various global locations and categorizing them based on regulatory guidelines to ensure compliance and meet commercial needs. Additionally, preparing variation packages for different modules and responding to deficiencies is crucial for supporting commercial launches and maintaining regulatory compliance. Furthermore, preparing annual reports for the US market, WHO requalification dossiers, and re-registration dossiers are essential to secure product licenses for business continuity. The efficient management of product databases aids in easy retrieval and status tracking, further enhancing business continuity efforts.

2.How does your previous work experience in Regulatory Affairs/Quality Assurance/Quality Control/Manufacturing/Analytical Development/R&D align with the requirements of this role? Answer: My previous work experience has equipped me with a strong understanding of regulatory guidelines and quality standards in the pharmaceutical industry. During my tenure, I have actively participated in the preparation of regulatory submissions, ensuring compliance with various international markets, including the US, EU, South Africa, ANZ, WHO, and PEPFAR. This experience has honed my analytical and problem-solving abilities, enabling me to assess change requests efficiently. Moreover, my exposure to product development and manufacturing processes has given me a comprehensive understanding of life cycle management activities, making me well-suited to contribute to business continuity efforts for Non-respi products.

3.How do you ensure effective communication and collaboration with global stakeholders while handling change requests for different markets? Answer: Effective communication and collaboration are paramount when dealing with global stakeholders in the life cycle management process. To ensure successful interactions, I prioritize clarity of thought and comprehension when reviewing change requests. I proactively engage in discussions with relevant teams and regulatory authorities from various countries to address any queries or concerns. Moreover, I utilize presentation and interpersonal skills to convey information accurately and concisely. By fostering a strong sense of teamwork, I aim to create a collaborative environment where all stakeholders work towards a common goal of business continuity for Non-respi products.

4.How do you approach challenges related to maintaining product licenses and regulatory compliance across multiple countries? Answer: Handling challenges related to product licenses and regulatory compliance requires a systematic and proactive approach. Firstly, I thoroughly research and understand the regulatory requirements of each country where the product is marketed, ensuring no essential details are overlooked. Secondly, I maintain meticulous documentation and data integrity, ensuring that all information is up-to-date and readily accessible for timely submissions. Thirdly, I leverage my problem-solving abilities to address any deficiencies promptly, collaborating with cross-functional teams to prepare variation packages and requalification dossiers effectively. Additionally, I stay updated with industry trends and regulatory changes to adapt swiftly to evolving requirements, thereby ensuring seamless business continuity across 150+ countries for Non-respi products.

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