Senior Manager - P&DD

Job Title:

Sr. Manager – Packaging Development

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G9B/A

Location

Halol

Responsibilities:

• Monitoring of New Product-Packs – Commercial Launches.


• Monitoring of Existing Product-Packs – Revision to comply latest Regulatory / Manufacturing requirement.


• Monitoring of Packaging Process Validation.


• To monitor / carry out documentation related to Packaging Process Development batches (e.g., Feasibility batches, Optimization batches, scale up batches, Stability batches, Pilot bioequivalence & clinical trial batches, Exhibit batches, Registration batches etc.) as per provided plan & checking /review of related documents.


• Facilitation for Procurement and approval of Packaging change parts


• Alternate Vendor Development / Cost effective /Productivity enhancement exercises.


• Packaging documentation for routine as well as continuous technology improvement activities


• Responsible for post launch trouble shooting on ongoing commercial products


• Audit / Inspection related activities.


• Identify need for fresh guidelines & scope of Improvement & drafting relevant guidelines and ensure its implementation.  


• Investigation of packaging related market complaints / OOS / OOT / Deviation & implementation of corrective and preventive actions as required.


• SOP creation/revision and implementation.


• Review & approval of SOP.


• Supporting R&D and Plant for technology transfer of Packaging.


• Support and execution of site transfer products.


• Resource planning / Work assignment /Job allocation.


• Ensuring Quality compliance as basis for all documentation.                 


• Budgeting (Revenue, Capital, IT and Manpower).


• Review and approval of QMS related records from Track wise.


• Exploring Developmental training for subordinate’s development.


• Attending CFT and QRB meetings, drawing action plans and ensures its smooth implementation.      


• Review & approve the artwork (For filling / trial / commercial product)


• Co-ordinate with CFT’s and machine manufacturer to resolve the related issues of packaging machinery.


• Co-ordinate with CFT’s and supplier / manufacturer of packaging material to resolve the material related issues.


• Co-ordinate to ensure the URS as per packaging material / current regulatory guidance.


• Co-ordinate to ensure the timely completion of FAT / SAT of new equipment’s.


• To ensure the smooth operation of equipment.


• To identify the new equipment as per plant requirement.


• Co-ordinate to ensure the respective documents for smooth operation & filling of new drug product (MPC / Pack Style / EBPR / IBPR / SPEC / ATP).


• To review the trial reports and other developmental documents.

Regulatory query

NA

Job Requirements

Educational Qualification

Graduate : Pharma or Science Gradute with PG Dip in Packaging Development from IIP

Experience

Tenure : minimum 15 years  of relevant experience

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Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).