Job Description

Division

IPD

Department

Ellipta & Devices

Job Purpose

Purpose of this job is to develop, build and maintain DMF for standalone and diagnostic devices with proper quality standards, TPP and protocols, Develop device DHF for regulated markets and combination product device elements as per ISO and IEC standards. The role of the job is to ensure department compliance to equipment calibration protocols, internal audits, safety audits

Key Accountabilities (1/6)

Develop, build and maintain device master files for standalone and diagnostic products

• Define the drafts, processes, and copies of device master file
• Prepare and maintain DMF for standalone and diagnostic devices with the help of individual associates on the development program
• Act as a data custodian to archive the filed DMFs and any upgradation/new geography leverage (e.g. CE, 510K)

Key Accountabilities (2/6)

Anchor suitable process documents to be submitted to agency as a part of device design history file (DHF) at Partner locations

Lead along with regulatory and QA functions to put together the requirements on manufacturing and scale up processes such as functional specifications, component certifications, biocompatibility study, robustness study protocols, recording of results and regulatory submission files

Key Accountabilities (3/6)

Response to agencies\' questions for submitted products

• Prepare responses to the queries from various regulatory bodies/agencies on the filed products in the approval process
• Obtain relevant information from suppliers, customers, regulatory dept. etc necessary to conduct any bridging analysis, studies in-lieu of the responses

Key Accountabilities (4/6)

Internal audits and compliance

• Lead and face internal audits for the department and support CQA for any external facing audits at the locations relating to the combination devices or standalone devices being manufactured
• Bring a compliance action plan and implement the same with the help of QMS analyst and in consultation with the Head of the Department

Key Accountabilities (5/6)

Upgradation proposals for the relevant SOP as per regulatory amendments

Define and propose to the DQA and ROCthe improvements in the existing SOPs, ELN task sheets required to be implemented at the department based on changes in regulatory notifications, internal processes and or new products being handled

Key Accountabilities (6/6)

Major Challenges

• Incomplete or inaccurate DHF can lead to rejection of the filed combination product DHF or Device DMF
• Lack of compliance to the current internal and external standards can lead to quality deviation and breach for the organization, resulting in delays, loss, or approval withdrawal.

Key Interactions (1/2)

Internal

• Cipla Devices team - device design understanding, DHF and DMF preparation (Daily)
• Regulatory - testing and validation protocols, drafts, new notifications, DMF to be maintained (Monthly)
• QA/QC- relevant certification and documentation for medical devices under scale up ( Fortnightly)

Key Interactions (2/2)

External

• Manufacturers - certifications, data, response to queries, change request, QMS files (Quarterly)
• Regulatory consultants - as required

Dimensions (1/2)

• Device files accepted by Manufacturing Quality and DQA - For the first to file approval, this is a critical milestone required to be achieved. Verification in terms of all design, process and scalability parameters is expected to be designed, recorded and approved from QA function.

Dimensions (2/2)

Product DHF acceptance by the Regulatory Agency - Ensures a stamp of approval is provided by the regulatory authorities on DHF- requires 12 months of rigorous program and process

Education Qualification

• Bachelors or Masters in Pharmaceutical sciences
• Diploma in or certification for any regulatory audits (e.g. ISO) highly welcome

Relevant Work Experience

• Demonstrated End-end knowledge of DHF of combination products and EU MDRs, Indian CDSCO filings - minimum 2 years of experience
• Exposure to quality internal audits, handling QMS systems, SOP and data management software packages

Cipla