139 Solid Orals Jobs

Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering Responsibilities Global Pay Plus Testers. MT MX messaging , SWIFT payments Preferred Skills: Banking-GPP Financial Services Domain-Payments-GPP Generic Skills: Banking

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

Responsible for manufacturing of all types of Tablet / Capsule / Powder (FDA Approval Must) Responsible for timely delivery with Quality and Quantity Responsible for motivation and handling of manufacturing workforce New Product Development Conduct Technical Non Technical Trainings Manufacturing of Tablet Capsules (Ayurvedic Allopathy) Predict, handle and rectify manufacturing defects Man management skills Knowledge of GMP guidelines Efficient in Documentation 2 - 3 Yrs at junior / executive position of similar profile

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.

End-to-end formulation and development of injectable dosage forms (Liquid, Lyophilized, Emulsion, etc.) Handling of scale-up, exhibit batches, and tech transfer Cross-functional coordination with ADL, RA, QA, and Manufacturing

1. Preparation and Maintenance of SOPs, STPs, Specifications, GTPs and Worksheets related to Product testing. 2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing. 3. Responsibilities for preparation of masters (Product, Specifications, Tests, worksheets, Test plans and TTD etc.) in LIMS. 4. Responsibilities for effective documents (STPs, Specifications and GTPs etc.) uploaded in LDMS. 5. Responsible for material management like weekly, monthly indent Ensure monthly indents are placed and materials received in timely manner, reservation placed through SAP. Ensure compliance `w.r.t expiry, usage and discard of materials. 6. Operation and calibration of QC Instruments related to product testing. 7. Testing and release of product samples by techniques such as: General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.) Gel Electrophoresis (IEF, SDS-PAGE, etc.) Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.) Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD @ 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.) ELISAs (Host Cell derived Proteins, Protein A Leachate, etc.) Q-PCR (Host Cell DNA, Mycoplasma testing etc.) HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.) UPLC techniques (Cation exchange chromatography, Protein A Chromatography, N-Linked Glycans by hydrophilic liquid interaction chromatography, etc.) 8. Preparation of reagent solutions, buffers and maintenance of the records. 9. Temperature and humidity monitoring of labs and instruments. 10. Sample receiving, A.R. No allotment, Testing, Documentation and reporting of analytical results in LIMS for In process, batch release, stability and Miscellaneous samples related to product testing. 11. Withdrawal and aliquoting of batch release and stability samples for analysis. 12. Responsible for preparation of shift schedules and test planning activities. 13. Responsible for cGLP compliance. 14. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing. 15. Responsible for change management: Ensure CRNs initiation and closure within target date. 16. Preparation, revision and review of miscellaneous protocols and reports related to product testing. 17. Review of analytical data and work sheets related to product testing. 18. Maintenance of stability samples and reserve samples related to product testing. 19. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. 20. Responsible for usage, monitoring and verification of all kind of laboratory books. 21. Preparation, execution and review of reference standard qualification. 22. Maintenance of all QC documents related to product testing. 23. Assist in execution of Analytical method validations.

1.Responsible for giving line clearance between startup of various finished product formulation and filling operations. 2.Responsible for performing in process checks during finished product operations as per respective established procedures. 3.Responsible for Monitoring and Coordination of process validation, Hold time studies, media fill and cleaning validation activities. 4. Responsible for preparation of IPQA SOPs and review of finished product SOPs. 5. Responsible for preparation of Annual Product Review Reports. 6. Responsible for continued process verification reports. 7.Responsible for compliance to GMP in finished product area. 8.Responsible for review of all finished product log books. 9.Responsible for review of master MFR and executed BFRs. 10.Responsible to attend training programs and SOP trainings. 11.Responsible for preparation of media fill BFR, protocol and report. 12.Responsible for monitoring of stability samples. 13.Responsible for preparation and review of visual inspection qualification protocol and report. 14.Day to Day Manufacturing observations Report to Manager QA.

Lead formulation and process development of HFA-based MDI products for regulated markets (US, EU, etc.). Manage drug-device combination product development , including coordination with device vendors for CMC and regulatory compliance. Coordinate cross-functionally with analytical, regulatory, clinical, and manufacturing teams to ensure timely project execution. Drive process optimization at the lab scale using QbD principles; establish control strategies for successful scale-up. Design and define product specifications in compliance with current global regulatory guidelines. Review Product Development Reports, Technology Transfer Reports , and Deviation/Investigation Reports for technical accuracy. Support regulatory query responses related to product development and manufacturing in collaboration with relevant departments. Lead technology transfer of HFA-based MDIs to contract manufacturing organizations (CMOs) for domestic and international markets. Provide technical and regulatory support for submissions including NDA, ANDA, and 505(b)(2) applications. Troubleshoot formulation-related issues during manufacturing to ensure smooth and compliant commercial production.

Development and validation of analytical methods for injectable dosage forms Stability study execution and data interpretation Support for formulation development and regulatory submissions (US/EU) Instrument handling: HPLC, GC, UV, KF, etc. Preparation of method validation reports, protocols, and SOPs

1. Responsible for operation and cleaning of PFS/Vial filling stoppering and Sealing machine. 2. Responsible for operation and cleaning of Lyophilizer machine. 3. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 4. Responsible for operation and cleaning of HPHV steam sterilizer. 5. Responsible for cleaning, preparation of machine parts and loads as per load pattern. 6. Preparation and filtration of disinfectants, IPA etc., 7. Responsible for area and equipments cleaning in FP facility. 8. Handling of APA equipments and to be involved in personnel gowning qualification. 9. Online Execution of Batch documents and related logbooks. 10. Handling of various types of filters and filter integrities. 11. Execution of preventive maintenance plan for equipments in coordination with engineering. 12. Maintaining of day to day activities in manufacturing areas. 13. Performing DQ, IQ, OQ, and PQ for the equipments in aseptic processing area and other associated areas.

1. Responsible for operation and cleaning of PFS/Vial filling stoppering and Sealing machine. 2. Responsible for operation and cleaning of Lyophilizer machine. 3. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 4. Responsible for operation and cleaning of HPHV steam sterilizer. 5. Responsible for cleaning, preparation of machine parts and loads as per load pattern. 6. Preparation and filtration of disinfectants, IPA etc., 7. Responsible for area and equipments cleaning in FP facility. 8. Handling of APA equipments and to be involved in personnel gowning qualification. 9. Online Execution of Batch documents and related logbooks. 10. Handling of various types of filters and filter integrities. 11. Execution of preventive maintenance plan for equipments in coordination with engineering. 12. Maintaining of day to day activities in manufacturing areas. 13. Performing DQ, IQ, OQ, and PQ for the equipments in aseptic processing area and other associated areas.

Operation and calibration of QC Instruments related to product testing. Testing and release of product samples by techniques such as: General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.) Gel Electrophoresis (IEF, SDS-PAGE, etc.) Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.) Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD at 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.) ELISAs (Host Cell derived Proteins, Protein A Leachate, etc.) Q-PCR (Host Cell DNA, Mycoplasma testing etc.) HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.) UPLC techniques (Cation exchange chromatography, Protein A Chromatography, N-Linked Glycan by hydrophilic liquid interaction chromatography, Peptide mapping, Size exclusion chromatography etc.) Capillary electrophoresis. Temperature and humidity monitoring of labs and instruments. Responsible for cGLP compliance. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. Responsible for usage, monitoring and verification of all kinds of laboratory books. Assist in execution of Analytical method validations

Lead global industry marketing programs Drive and execute sponsorship & participation in industry events Develop marketing artefacts and collateral along with messaging for the website Formulate & work with Inside Sales & external vendors on demand-gen programs Support the analyst relations program & garner mentions by driving participation in relevant studies

Role & responsibilities Responsible for Pre-formulation studies for lab formulation development trials of solid orals, Oral Liquid, injectable, products, and Nutraceuticals product. To design strategy for projects through literature surveys. Respective API characterization, excipients characterization, drug and excipient study and its ratio. Worked on different manufacturing strategies for the development of products. To evaluate product for stability in manufacturing, monitor and review the stabilized batches. To study on existing formulations. Responsible for co-ordination, execution and monitoring of scale up activity, Responsible for Trial batches, Scale up batches, Optimization batches, Exhibit batches. Co- ordination with all cross-functional teams. TT sites and LL Sites To design/assist/support/ review for documents such as SOP, LNB, QQ, Risk assessment, PDR, MFR, Scale up BMR, stability protocol, qualification, validation documents, change controls, deviations, investigations and CAPAs etc. Preferred candidate profile pharma THANKS YOU REGARDS MILAP RATHOD (7486829377) any time call me or whtup HR DEPARTMENT OPES HEALTHCARE PRIVATE LIMITED

We are a Pharma Mfg located in Dabaspet. We are looking to hire QA Executive for our Tablets mfg and pkg dept. who will be dedicated full time. B.Pharma. Minimum Exp. (3-5 years OSD formulation). Interested send resume to watsapp 9739978848

Position : Block Head Production (OSD) Location : Sikkim Grade - Senior Manager-2 Position Summary This role is responsible for overseeing the operations of a specific c block within the manufacturing facility, ensuring efficient production processes, compliance with quality and safety standards, and meeting production targets. To meet the production targets To ensure the implementation of current Good Manufacturing Practices and SOPs at work place To maintain and improve the product quality as per standard To ensure Accuracy, Reliability, validity, integrity and completeness of the cGxP data/records To plan the department activities as per weekly delivery schedule for OSD and Liquid orals To ensure the eff ective control on man, machine and material in the department To participate and coordinate various on-going qualifi cation and validation activities Collaborate with the site quality head, QA & QC head in ensuring that the production is aligned to the qualitystandards and regulatory requirements To ensure the completeness of all the trainings (Sops, Technical, Developmental and Regulatory etc.) assigned toblock personnels To organize and implement the on-job training activities in the department To ensure the implementation of EHS practices during work To ensure the maintenance of equipment and upkeep of department constantly To control the rejection during manufacturing and packing operations To do counseling and grievance handling of the subordinates To prepare, review and approve the Standard Operating Procedures To evaluate deviations, change controls and other quality documents for appropriate conclusion To ensure the market compliant investigations as per the track wise module and its timely closure and awarenesstraining to all the concerned persons Handling of QMS related activities of Block To carry out the batch failure investigation for root cause identification and accordingly appropriate corrective action and preventive action taken To review and approve the equipment qualification protocols, process validation protocols, reports, specifications etc.

Job Description: Blister Packing Machine Operator ( BQS- Primary & Secondary) ( No. of positions- 02 nos.) To perform daily activities of Blister Packing area. Well versed with the BQS Primary or Secondary machine handling. (Make BQS Primary- ACG Pam pack, BQS Secondary- ANTRAS). To perform weighing balance calibration & verification activities. To record and maintain proper documentation of production area along with area log books. 2. Coating Operator (No. of positions - 01 nos.) To perform daily activities of Coating area. Well versed with the Coating machine handling. (Make Kevin Autocoater). To perform weighing balance calibration & verification activities. To record and maintain proper documentation of production area along with area log books. Interested candidates can share their resumes on below mentioned E-Mail ID's: n32admin@v-ensure.com career@v-ensure.com a.salunkhe@v-ensure.com Interested candidates can also reach on 8356911996 for further details. While sending the resume mention your expertise area in the subject line & mention below details in the mail body: Current CTC Expected CTC Notice period Total Experience Reason for change

Walk-in interview For Sun Pharmaceutical Industries Limited, Dadra Date: 20th July 25 (Sunday) We are recruiting for our OSD manufacturing facility located at Dadra Time: 10 AM to 4 PM Interview Venue: Sun Pharmaceutical Industries Ltd, Survey No. 694, Dadra - 396193, (U.T. of D & N. H.), India, Following are the requirements for our manufacturing facility at Dadra Location. 1) Designation: Officer / Sr. Officer / Executive Granulation & Packing Education: B. Pharm / M. Pharm Department: OSD Manufacturing & Packing Experience: 2- 6 years of experience in OSD manufacturing handling Granulation, Compression, Tablet Coating, Tablet Inspection, and Bottle Packing activities in an OSD manufacturing plant, should have knowledge of cGMP. 2) Designation: Technician Manufacturing & Packing Education: ITI / Diploma/ B. Sc Department: OSD Manufacturing & Packing Experience: 3 - 7 years of work experience in pharmaceutical company, handling Granulation, Compression, Tablet Coating, Tablet Inspection and Bottle Packing activities in a regulated manufacturing plant. For all the positions, we are looking for candidates with experience in regulated plants like USFDA, MHRA, ANVISA, TGA etc. Interested candidates meeting with criteria should carry their updated resume along with photograph, Photocopy of Salary Supporting/Appointment/latest Increment letters giving salary breakups of Monthly & Annual Salary is must. Those who are unable to attend the personal interview may send their resume by e-mail to rupeshkumar.upadhyay@sunpharma.com

Looking candidates for PDR (Formulation & Development ) Dept. 5-10 years of relevant experience in solid oral dosage (Regulated Market US & Europe) Roles and Responsibilities 1.Candidate should perform literature search 2.Pre formulation development Required Candidate profile 1.knowledge of documents – Master formula card, Bill of Material, stability protocol 2.Preparation of various documents like PDR, stability protocol, development report writing FDR/PDR

Walk-in @ Indore We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned, If any of the requirement is matching your current job profile, kindly walk-in with your latest resume. *Job Location: Matoda, Ahmedabad, Gujarat. Engineering (Instrumentation / QMS / Process Equipment maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech with relevant functional experience in Calibration / Instrumentation / QMS activities QUALITY ASSURANCE QMS / Documentation / Validation and Qualification / IPQA (OSD) (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. QUALITY CONTROL (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M.Sc. (Organic Chemistry / Analytical Chemistry) B. Pharmacy / M Pharmacy MICROBIOLOGY (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M. Sc (Microbiology) Injectable Manufacturing (Executive/Senior Officer / Officer / Associate) Experience - 01 to 06 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma with relevant functional experience in injectable manufacturing/ Aseptic area operations / Visual inspection / QMS activities OSD Manufacturing (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing operations / QMS activities Time and Venue : 20th July 2025 09:30 Hrs to 18:00 Hrs ______________________________________________________ PAPAYA TREE Group of Hotels - Indore, Address: AB Road , Near Dr. Hardia Eye Clinic, Rau, Indore, MP ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Note: Having relevant qualification only can attend the scheduled walk-in.

Position: AM_ ADL Key Requirements: Conducting in-depth Literature and patent search and making formulation development plan for Solid oral and Liquid oral formulations Develop new formulation concepts, assists in the development of project plans, business analysis and feasibility assessments. Develop experimental programs, work plan and prioritize assignments to meet project objectives within defined timelines Review and analysis of experimental data and design of further experiments. Monitoring of stability studies and Data interpretation Formula and process optimization studies - Discussion/design, review and monitoring of PET trials, pH Establishment Trials and PDR Trials Identify and manage the potential risks within projects in a timely fashion Arrange and management inventories (RM, PM, RLD etc.) required for projects. Conducting root cause analysis and trouble shooting Co-ordinate with cross functional teams for smooth flow of projects Review of technical documents like QnQ, Draft specifications, PDR report and finalization, MFR, PVP, HTSP etc. Monitoring and providing technical support for scale up and validation batches Desired qualifications: M. Pharma Desired skills: Proactive self-starter who is comfortable working independently in a fast-paced environment while maintaining attention to detail Hands on experience in formulation development of solid orals and liquid orals for regulated markets Knowledge on QbD and DoE concepts Knowledge on Regulatory guidelines for USA/Europe/ROW markets Trouble shooting and Root cause analysis skills

Alembic Group is looking for Assistant Manager - Formulation Development to join our dynamic team and embark on a rewarding career journey Ensuring company policies are followed. Optimizing profits by controlling costs. Hiring, training and developing new employees. Resolving customer issues to their overall satisfaction. Maintaining an overall management style that follows company best practices. Providing leadership and direction to all employees. Ensuring product quality and availability. Preparing and presenting employee reviews. Working closely with the store manager to lead staff. Overseeing retail inventory. Assisting customers whenever necessary. Organizing employee schedule. Ensuring that health, safety, and security rules are followed. Ensuring a consistent standard of customer service. Motivating employees and ensuring a focus on the mission. Maintaining merchandise and a visual plan. Maintaining stores to standards, including stocking and cleaning. Completing tasks assigned by the general manager accurately and efficiently. Supporting store manager as needed.

Alembic Group is looking for Senior Manager - Formulation Development to join our dynamic team and embark on a rewarding career journey Delegating responsibilities and supervising business operations Hiring, training, motivating and coaching employees as they provide attentive, efficient service to customers, assessing employee performance and providing helpful feedback and training opportunities. Resolving conflicts or complaints from customers and employees. Monitoring store activity and ensuring it is properly provisioned and staffed. Analyzing information and processes and developing more effective or efficient processes and strategies. Establishing and achieving business and profit objectives. Maintaining a clean, tidy business, ensuring that signage and displays are attractive. Generating reports and presenting information to upper-level managers or other parties. Ensuring staff members follow company policies and procedures. Other duties to ensure the overall health and success of the business.

Alembic Group is looking for Junior Executive - Formulation Development to join our dynamic team and embark on a rewarding career journey They work under the guidance of senior executives and managers to support the organizations goals and objectives Must have excellent written and verbal communication skillsMust be able to analyze complex problems and develop effective solutions Managing internal and external communication, including preparing reports, presentations, and other materials

Alembic Group is looking for Executive - Formulation Development to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.