F&D/R&D -Asst. Manager/Manager

Gepach International; Pithampur; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Gepach International in Pithampur, MP, invites a skilled pharmaceutical professional to lead new product development and oversee pilot manufacturing activities for oral solid dosage forms. You will ensure cGMP compliance, manage cross-functional coordination, and drive process improvements in daily operations.

Qualifications include excellent communication, systematic problem-solving, and strong MS Office skills; English fluency is essential.

Qualifications

• Excellent communication skills.
• Systematic approach to solving problems.
• Detail-oriented with ability to multitask.
• Proficient in using the internet as a information tool.
• Must be fluent in English and proficient with MS Office.

Responsibilities

• New product development and troubleshooting in the oral solid dosage forms.
• Candidates having experience of Effervescent Tablets and Lozenges manufacturing/ development will be preferred.
• Manage manufacturing activities in Pilot Manufacturing Area to ensure daily operation as per plan.
• Ensure cGMP compliance, QMS activity, product quality, process, personnel and material flow with online completion of batch records and equipment/area logbook at Pilot Manufacturing Area.
• Co-ordinate with store, QA, QC Engineering, Purchase, HR and other departments of plant.
• Schedule the weekly and monthly plan for Pilot Manufacturing Area as per New Products plan, to resolve product issues related to manufacturing process.
• Supervision and execution-resolve day to day issues related to production process, documentation, product quality, material rejection and compliance activity of Pilot Manufacturing Area.
• To ensure compilation of trial batch report, implementation of changes in validation and commercial batches.
• Participate in investigation of any product related complaint from market and handling of change controls, deviation with co-ordination of different departments and identifying the root cause and appropriate CAPA.
• To ensure that all required (cGMP, SOPs, on job, BMR, BPR, etc.) initial and scheduled training of all department personnel to be carried out and adapted accordingly to need base.
• To ensure that all the staff and workers are following safety guideline while working in the area and are wearing adequate PPE at the time of operation.
• To improve the yield of the products and saving costs wherever possible.
• Having experience in PDR preparation

Skills

Communication skills

Systematic problem solving

Detail oriented

Internet research

English fluency

Tools

MS Office

Job description

Role & responsibilities

• 1. New product development and troubleshooting in the oral solid dosage forms


• 2. Candidates having experience of Effervescent Tablets and Lozenges manufacturing/ development will be preferred.


• 3. Responsible for managing of manufacturing activities in Pilot Manufacturing Area to ensure daily operation as per plan.


• 4. To ensure cGMP compliance, QMS activity, product quality, process, personnel and material flow with online completion of batch records and equipment/area logbook at Pilot Manufacturing Area.


• 5. To co-ordinate with store, QA, QC Engineering, Purchase, HR and other departments of plant.


• 6. Scheduling the weekly and monthly plan for Pilot Manufacturing Area as per New Products plan, to resolve product issues related to manufacturing process.


• 7. Supervision and execution-resolve day to day issues related to production process, documentation, product quality, material rejection and compliance activity of Pilot Manufacturing Area.


• 8. To ensure compilation of trial batch report, implementation of changes in validation and commercial batches.


• 9. To participate in investigation of any product related complaint from market and handling of change controls, deviation with co-ordination of different departments and identifying the root cause and appropriate CAPA.


• 10. To ensure that all required (cGMP, SOPs, on job, BMR, BPR, etc.) initial and scheduled training of all department personnel to be carried out and adapted accordingly to need base.


• 11. To ensure that all the staff and workers are following safety guideline while working in the area and are wearing adequate PPE at the time of operation.


• 12. To improve the yield of the products and saving costs wherever possible.


• 13. Having experience in PDR preparation

Required Candidate profile

Excellent oral and written communication skills and ability

• The candidate must have a systematic approach to solving problems.


• A detail-oriented candidate with the ability to manage several tasks at once while prioritizing for achievement within deadlines.


• Should be proficient with the usage of the internet as a tool to find necessary & useful information.


• Must be fluent in English and familiar with MS Office (Word, Excel, PPT)

Perks and Benefits

Salary not a constraint for the right candidate based on potential and experience .

Requirement: Be willing for immediate appointment, if selected .6-11 years experience in research and development specifically in F&D ( Formulation & Development) in Pharmaceutical industry and at least Five years in a similar role will be preferred. .