Formulation Development (Documentation) - Senior Executive

Job Summary

1. Preparation of various master documents required for the submission batch execution and supports the product development by preparation of documents like master production records, Master Packing records and various reports like Exhibit Batch Summary Reports, Hold Study reports, Photo stability Reports, Transportation worthiness study report, Bulk product Stability Reports, SOPs and other miscellaneous reports.
2. Responsible for Maintenance & updating of proper inventory of all the change parts and accessories for the equipments and Instruments.
3. Indenting the punches, dies & machine change parts for the development and submission batches. Issuance of Logbooks for the new equipments, instruments, punches and dies.
4. Preparation of Purchase indents in SAP for the procurement of raw and packing materials.
5. Supporting the other sub-ordinates in learning of the equipments, system and process.
6. Perform all work in accordance with established regulatory, compliance and safety requirements.
7. Works in a safe manner collaborating as a team member to achieve all outcomes.
8. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
9. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
10. All other relevant duties as assigned related to Docuemntation & change controls

Job Responsibilities

• To prepare various documents like SOP’s, Formats, protocols, Reports, Master formulas, SMM, SPM etc., for the Formulation Development Laboratory.
• To maintain and safeguard the equipment and other properties of company that is assigned for the purpose of use in processes.
• To maintain the safety and housekeeping practices at work place.
• Practice and up-gradation of knowledge with respect to cGMP.
• To maintain online documents for the activities carried out by him in the area.
• To carry out the activities assigned on to him by the concerned Research Scientist / Senior Research Scientist.
• Produce quality products by following GMP practices and maintaining the yields / reducing the packaging materials waste.
• To co-ordinate with other area technicians for the necessities, in his role to handle the other area and getting trained.
• To receive, check, issue and dispense raw materials and packaging materials.
• To be responsible for all activities in the Day Stores and Pilot plant including cGMP, documentation and implementation of departmental quality systems.
• To generate and maintain records involving the receipt, checking, issue and dispensing of raw materials and packaging materials.

Job Requirements

• Education
  • University / College degree in Chemistry, Pharmaceutical Technology, or related science preferable B. Pharm/ M Pharm (Pharmaceutics)
• Knowledge, Skills and Abilities
  • Should have good communication knowledge of English (Speaking, Reading and Writing).
  • Should have skills in Microsoft Word, Excel and working knowledge in SAP. Knowledge of the Pharmaceutical manufacturing Process and cGMP is desirable.
  • Should have the attitude of performing the allotted activities in compliance with all the established procedure with an aim to develop Quality Pharmaceuticals.
  • Should take ownership for quality in the job, support our corporate values of Collaboration, Courage, Perseverance, and Passion.
• Experience
  • Should have minimum 5 years experience in Technical Writing in the pharmaceutical industry/ GMP environment and overall 8-10 years working knowledge of Formulation Development, Manufacturing process in pharmaceutical industry.