Abasaheb Karad

# Management of production and packaging activities of ampoules and vial injectable formulations to execute commercial production activities in Block C.

# Handling of project activities in the packaging area, and execution of Exhibit batches for regulatory filing, as per customer requirements for ophthalmic and pre-filled syringe formulations in Block J.

# Follow up and support for QMS and shop floor document completion and on-time submission to QA.

Problem-solving and troubleshooting of production and packaging machines, with the support of the engineering department and vendor, as per requirements.

# Manpower management, i.e. Work allocation, training and development as per requirement, performance meetings, motivation, and support to achieve the organization and personnel goals. Coordinating with cross-functional department personnel for the completion of day-to-day activities, and problem resolution.

Vendor and material management to ensure the availability of required consumables, primary, and secondary packaging materials, to perform day-to-day production activities.

Achievements:

Handling of two block activities, i.e., commercial production in Block C, and project activities in Block J.

Handling of the improvement project on the vial line, i.e. Raised rubber stopper and aluminum seal identification system, installation of dynamic pass box, and extended LAF.

Qualification of the automatic visual inspection machine (Hitachi).

Installation and Qualification of Packaging line for Ophthalmic formulations.

Responsibility:

# Management of filling, visual inspection, and packaging activities of biotech products, like Sputnik vaccine, biosimilars (Adalimumab, Aflibercept, etc.) and human recombinant albumin with pre-filled syringes and vial formulations.

# Handling of project activities in the packaging area and vial filling suite (qualification and validation activities of related equipment/instruments, and successful execution of initial media fill runs).

# Handling of QMS and shop floor documentation (deviations, OOS, change controls, risk assessment, CAPA actions, etc.). Master documents like BMR, BPR, SOPs, etc.

# Manpower management, i.e. Work allocation, training and development as per requirement, performance meetings, motivation, and support to achieve the organization and personnel goals. Coordinating with cross-functional department personnel for the completion of day-to-day activities and problem resolution.

Vendor and material management to ensure the availability of required consumables, primary and secondary packaging materials, to perform day-to-day production activities.

Achievements:

Executed 3 CT batches and 15 commercial batches of different products, from the start-up of the greenfield project to the commercialization of the product. Also, 12 media fill batches were executed successfully, without failure, to support the continuous production activities to achieve the organization's goal.

The project of the Vial Filling suit (installation, qualification, and validation) was completed in 7 months against the timeline of 8 months, and the initial media fill batches were successfully completed.

I worked as a Packaging Development Lead at the site and developed packaging materials with artwork for three commercial products.

I participated in a cGMP and Good Documentation Practices awareness competition (Data Integrity and ICH Q10) organized by the QA site head at the site and won first place out of 240 participants, which shows my knowledge of cGMP and Good Documentation Practices, as well as my involvement in production processes.

Responsibility:

Management of visual inspection and packaging activities of injectable products like testosterone cypionate and Medroxyprogesterone acetate.

# Handling of QMS and shop floor documentation (deviations, OOS, change controls, risk assessment, CAPA actions, etc.). Master documents like BMR, BPR, SOPs, etc.

# Manpower management, i.e. Work allocation, training and development as per requirement, performance meetings, motivation, and support to achieve the organization and personnel goals. Coordinating with cross-functional department personnel for the completion of day-to-day activities and problem resolution.

Vendor and material management to ensure the availability of required consumables, primary and secondary packaging materials, to perform day-to-day production activities.

Achievements:

I worked as a Visual Inspection SME at the site and developed visual inspection kits in-house for three products. Also, the procurement of professional visual inspection kits from M/s Micro Measurement Ltd., USA, was done successfully.

# Part of the CAP team (Compliance Action Plan) for USFDA audit observations received during the audit in October. 2019. During this activity, a total of 400 observations were given to different units, and later, the compliance of the other team's observations was completed.

I worked as a QMS lead for the production department for 10 months and handled a team of 4 people.

Responsibility:

Management of packaging activities of injectable formulations, like Fulvestrant and Daptomycin Injection commercial products, and other exhibit product batches.

# Worked on the Werum system (PAS).|X) to execute documentation digitally.

# Handling of QMS and shop floor documentation (deviations, OOS, change controls, risk assessment, CAPA actions, etc.). Master documents like BMR, BPR, SOPs, etc.

# Manpower management, i.e. Work allocation, training and development as per requirement, performance meetings, motivation, and support to achieve the organization and personnel goals. Coordinating with cross-functional department personnel for day-to-day activity completion and problem resolution.

Achievements:

# Part of the US FDA audit preparedness team. During this activity, a total of 150 observations were identified in the units, and compliance with the same has been done.

Responsibility:

Management and supervision of filling, and packaging activities of eye drop formulation at Cipla Ltd.

# Preparation of the monthly plan as per the monthly planning meeting.

# Handling of QMS and shop floor documentation (deviations, OOS, change controls, risk assessment, CAPA actions, etc.). Master documents like BMR, BPR, SOPs, etc.

Shop floor activities of each section, i.e., filling and packing, have been learned and executed to achieve the yearly goal of commercial product batches.

# Shop floor activities on oral liquid, nasal spray, and FFS packaging lines during the Eye Drops line modification period.

# Manpower management, i.e. Work allocation, training and development as per requirement, performance meetings, motivation, and support to achieve the organization and personnel goals. Coordinating with cross-functional department personnel for day-to-day activity completion and problem resolution.

Achievements:

Executed more than 2,000 commercial batches of different products and was involved in dispensing to dispatch activities to achieve the monthly plan (export as well as local), where more challenges were present on this line than on the other lines in the unit.

Promoted from line supervisor to section head during this period, I successfully managed the line activities to meet the organization's goals.

# Part of the simplification and cost-reduction project initiated by the Mackenzie Team at the site, where more than 10 simplification/cost-reduction projects have been completed.