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8.0 - 12.0 years
8 - 15 Lacs
Ahmedabad
Work from Office
Essential Duties and Responsibilities: Actively Support launch and sustenance of Baxter commercial products globally by following the Baxter Quality Management Systems. Assist in the management of the Baxter product design throughout the product lifecycle and maintenance of the product DHF, or similar product design governance documents for a particular product family. Identify and analyze design problems to achieve optimal solutions that satisfy cost and technical requirements. Formulate new, innovative approaches to solve technical problems on a consistent basis. Actively involve in commercialized product investigation, execute batches in laboratory, prepare report to support the investigation. Involve in compendial product change/proposal discussion, assess the proposed change impact on the product quality & patient safety. Provide support to analytical team by providing the required product solution/placebo solution samples. Execute batches in laboratory, assess the study outcome to support the compendial product change requirement. Ensure response to customer queries, agencies query, market compliance. Design and execute batches/experiments in laboratory, prepare report to support queries/market compliance. Responsible for ensuring the availability of required licenses and materials (raw material, packaging materials) in laboratory. Qualifications: Educational Qualification: Masters in Pharmaceutics or equivalent Hands on experience in laboratory batch execution and drive the towards the expected result. Good communication skills for effective liaison and teamwork Problem-solving skills, analytical skills and attention to detail Excellent organizational skills and the ability to work on several tasks or projects concurrently Presentation skills - for presenting ideas and findings to colleagues and customers Ability to work well independently, with minimum supervision Drive, enthusiasm and self-motivation
Posted 3 weeks ago
8.0 - 12.0 years
8 - 12 Lacs
Ahmedabad
Work from Office
Role & responsibilities Actively supports launch and sustenance of Baxter commercial product globally. Support all commercialized project related requirements related to Baxter manufacturing sites and CMOs Globally. Assist in the management of the Baxter product design throughout the product lifecycle and maintenance of product design governance documents for a particular product family. Make sure the relevant documents for various product families are available to support risk management, change control processes and design integrity. A very good understanding of Quality Risk Management for pharmaceutical products is required per ICH Q9 and ensure sustenance of Baxter commercial products globally by following Baxter Quality Management Systems. Respond to customer queries regarding safety aspects of the product after consultation with Clinical affairs and other relevant functions. Manage Platform core team performance, product life cycle, project schedule, execution, budget commitments and spend. Review weekly, monthly/yearly progress of the projects and send report to the governance team to implement the improvements suggested by the governance. Drive the discussion and ensure the implementation of VIP/ MIP projects, alternative vendor projects. Own supplier notification of change (SNC) or change control to support the implementation of change on time. Preferred candidate profile Educational Qualification: Masters in Pharmaceutics or equivalent Data Analysis and Good communication skills for effective liaison and teamwork Problem-solving skills, analytical skills and attention to detail Excellent organizational skills and the ability to work on several tasks or projects concurrently Presentation skills - for presenting ideas and findings to colleagues and customers Ability to work well independently, with minimum supervision Drive, enthusiasm and self-motivation An aptitude for mathematics and statistics and highly developed IT and technical skill Project management skills and having knowledge of MS office and project management tracking software (Microsoft project, primavera and Planisware) to track and monitor the project progress will be an added benefit.
Posted 3 weeks ago
2.0 - 5.0 years
3 - 4 Lacs
Thane, Ambernath
Work from Office
Role & responsibilities RM and PM receiving and documentation of the same. Proper arrangement of the Received COA of RM and PM. Sampling of Received RM and PM, sending the samples to ADL for analysis. Preparation of indent for trial activity and ensure the availability in defined time. Taking of daily trial batches, discussion of issue with immediate supervisor. Entry of trial batch data in lab notebook and preparation of BMR for stability batches. Maintaining the files of individual products like RM and PM COA, Trial COA and Stability Reports after updation in Excel Sheet. Ensure GMP practice in Laboratory routinely. Documentation of stability batches. Calibration of instruments in the laboratory. Literature search and review for the newly identified products for EU/UK/Raw market. SOP preparation and submission to DQA. Ensure utility in good condition in laboratory during all development batches. Adhere Good Manufacturing Practice and Good Laboratory Practice throughout lifecycle of the product. Preferred candidate profile Should have exposure to Formulation & Development of Injectable products knowledge for regulatory market preferable along with regulatory documents preparation like PDR, MFR etc. If having basic knowledge of injectable products is added advantage.
Posted 3 weeks ago
6.0 - 8.0 years
3 - 8 Lacs
Hyderabad
Work from Office
Responsibilities: Review IP landscape reports, non-infringement& FTO analysis Devise strategies for patent non infringement and invalidations Collaborate with R & D Scientist to explore design around strategies for P-IV & NCE products Conduct IP due diligence for product selection/ new opportunity identification. Support RA for patent certification, PIL clearances and declaration Monitor, review and manage ANDA litigations Conduct patentability searches, draft and file patent applications and manage prosecutions Ensure timely and effective task delivery through strategic planning prioritisation and execution.
Posted 3 weeks ago
7.0 - 8.0 years
7 - 8 Lacs
Hyderabad
Work from Office
PDR . ; SOPs.; CHANGE controls, deviations , incidents ; Master formula card, drug excipient study reports ; regulatory and customer audits. .Apply the Test Licenses and Narcotic-related licenses. Provident fund
Posted 3 weeks ago
1.0 - 6.0 years
2 - 3 Lacs
Ahmedabad
Work from Office
Role & responsibilities: Formulation development Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.
Posted 3 weeks ago
2.0 - 7.0 years
4 - 9 Lacs
Navi Mumbai
Work from Office
Pre-formulation studies lab formulation development trials of solid oral Literature survey, to design strategy for the formulation of the projects Day to day execution of the planned batches in laboratory Technology transfer activities to production Required Candidate profile email:-sunil@flamingopharma.com
Posted 3 weeks ago
1.0 - 5.0 years
6 - 12 Lacs
Hyderabad
Work from Office
Responsibilities: * Conduct formulation research & development. * Collaborate with R&D team on new product launches. * Develop protein-based food products. * Optimize food processing techniques. Food allowance Annual bonus
Posted 3 weeks ago
3.0 - 8.0 years
5 - 15 Lacs
Hyderabad
Work from Office
Job Description Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements. You will be responsible for designing and implementing stability studies for injectable formulations to ensure product quality and shelf life. You will be accountable for troubleshooting formulation and process-related issues during development and manufacturing stages. You will collaborate with cross-functional teams to ensure alignment of formulation development with regulatory requirements and commercial objectives. You will be responsible for staying current with emerging technologies and regulatory guidelines in injectable drug development and incorporating them into your work. You will mentor junior scientists and contribute to the continuous improvement of the formulation development process. Qualifications Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams.
Posted 3 weeks ago
8.0 - 10.0 years
4 - 7 Lacs
Baddi, Himachal Pardesh
Work from Office
Role & responsibilities 1. Performing Stability analysis, Method transfer and Method Validation. 2. Develop formulations for solid oral dosage forms (Tablets, Capsules) with expertise in compression, granulation, coating, OSD, and formulation development. 3. Conduct production monitoring activities to ensure compliance with quality standards. Desired Candidate Profile 4. Strong understanding of tablets, capsules, compression, granulation, coating processes; knowledge of OSD technology an added advantage. 5. Preparation and review of Method Transfer Protocols, Validation protocols and all related protocols, procedures and reports. 6. To carry out analytical method development, method validation and testing of impurities in finished products on LCMS/MS and GCMS/MS 7. RM (HPLC)GCTesting 5. Preparation, review of departmental SOPs and training of analysts. 6. Calibration and validation of instruments equipments. 7. Review and maintenance of all logbooks in the department. 8. Procurement of columns, chemicals/ reagents/ solvents and standards for Stability analysis, Method Transfer and Method Validation.
Posted 3 weeks ago
20.0 - 28.0 years
35 - 55 Lacs
Pune
Work from Office
Job Description: Head of Research & Development (R&D) Location: Pune, India Company: Star Engineers Pvt. Ltd. Position- Head - Research & Development (R&D) Location- Pune, India Experience- 20+ years in R&D, with at least 10 years in a leadership role in automotive electronics Reporting To - Managing Director / CTO / CEO Industry Preference - Automotive, Electronics Manufacturing, or Related Industries Educational Qualification - B.E./B.Tech (Electronics/Electrical/Embedded Systems) + M.Tech/Ph.D preferred Travel - Automotive Electronics, APQP, or Mechatronics Employment Type - Full-time, Permanent Travel - Occasional (Domestic and International, for customer/partner collaboration) Role Purpose: Objective Description Strategic Leadership To lead the R&D function with a focus on product innovation , technology advancement , and design validation to support Star Engineers position as a global leader in automotive electronics. End-to-end ownership Manage the complete product development lifecycle from concept to prototype to validation and final handover to manufacturing. Technology foresight Drive the development of next-gen automotive electronics aligned with EV, hybrid , and BS-VI/Euro VI emission trends, and ensure regulatory compliance. Collaboration Work cross-functionally with Production, Quality, Supply Chain, and Marketing , as well as OEM customers , to develop reliable, high-performance, and cost-effective products. Team development Build and lead a multidisciplinary engineering team , foster a culture of innovation, speed, and IP creation , and mentor future leaders in the organization. Key Responsibilities: Key Result Areas (KRAs)Key Performance Indicators (KPIs)Target/Measurement Metric1. New Product Development (NPD) Timely launch of new products aligned with customer and market needs Product roadmap implementation. Minimum 3- 5 new products launched per year 100% execution of NPD roadmap as per plan 2. Innovation & Technology Leadership Adoption of new technologies (e.g., IoT, EV platforms, smart sensors). Patent/IP generation Minimum 2 technology innovation projects annually 1-2 patents or IP filings per year 3. Product Design & Validation Robustness of design, endurance testing, and compliance Cost-effective design & manufacturability Zero test failures during validation for homologation 95% design acceptance by manufacturing & QA teams 4. Quality & Compliance Adherence to standards (IATF 16949, ISO 14000, AIS, ARAI norms, etc.). Customer satisfaction in product quality 100% compliance in audits and approvals 100 PPM defects in new product batches 5. Project Management On-time delivery of design milestones Resource utilization 90% projects delivered within timeline & cost Maintain 85% efficiency in engineering resource deployment 6. Team Development Training, mentoring, and talent retention Competency development. 100% team training completion & 5% attrition 2 - 3 team members promoted or moved into critical roles/year 7. Cross-Functional Collaboration Engagement with production, QA, SCM, and OEM customers Product feasibility and DFMEA/PFMEA effectiveness. Weekly or bi-weekly cross-functional review meetings. 95% closure of design issues before SOP 8. Cost & Value Engineering Design-to-cost performance Localization and alternate sourcing support Achieve 5 - 10% cost reduction per product line 30% localization in BOM with equivalent performance 9. Process Improvement Implementation of R&D best practices (APQP, V-Model, etc.). Reduction in product development cycle time Continuous improvement projects minimum 6 per year 15- 20% reduction in development lead time YoY 10. Strategic Alliances & Technology Partnerships Engagement with academia, startups, and tech partners 2- 3 active partnerships or collaborative projects annually Skills & Competencies Required: Technical CompetencyDetailsTechnical Expertise Strong foundation in embedded systems, sensors, control systems , EMI/EMC Innovation Mindset. Experience in new tech scouting, IP creation , and future mobility trends Product Lifecycle Knowledge Expertise in full product lifecycle from concept to SOP Project Management Strong in stage-gate, APQP , and project budgeting Leadership Ability to inspire, mentor, and grow a diverse R&D team. Cross-functional Collaboration Proven ability to collaborate with Manufacturing, QA, SCM, and Customers Compliance & Certification Deep knowledge of regulatory & homologation processes in automotive Tool Proficiency Hands-on with tools like Altium, Matlab, Simulink, DFMEA, PFMEA , etc. Preferred Background: Criteria Details Industry Experience - Automotive electronics, embedded control systems, EV systems. Certifications - Hands-on experience managing global and multi-location supply chains. Certifications (Preferred) Design Thinking, PMP, Six Sigma (preferred) Global Exposure Experience working with or for global OEMs/Tier-1 suppliers Languages - English (mandatory), Hindi, Marathi (preferred)
Posted 3 weeks ago
3.0 - 5.0 years
2 - 6 Lacs
Surat
Work from Office
* Conduct market research on ingredients & trends * Develop new products through R&D process * Transfer technology from lab to production line * Collaborate with cross-functional teams on formulations * Making Samples as per requirements Provident fund
Posted 3 weeks ago
4.0 - 9.0 years
5 - 11 Lacs
Bhiwadi
Work from Office
Job Description: We are seeking a highly motivated and experienced professional for our Formulation and Development team in the R&D department. The ideal candidate will have a strong background in formulating Solid Oral dosage forms (OSD), Liquid orals, Semi solid or Topicals and experience in product development, scale-up, and technology transfer . Key Responsibilities: Literature review and Patent search Preparation of master formula card, Qbd product development report & other protocols. Design and develop formulations for new and existing pharmaceutical products. Conduct pre-formulation studies and compatibility testing. Execute lab-scale and pilot-scale batch manufacturing. Coordinate with analytical, regulatory, and production teams for seamless development. Prepare technical documents including MFRs, PDRs, development reports, and protocols. Handle technology transfer to manufacturing sites. Troubleshoot formulation and process-related issues during scale-up and validation. Ensure compliance with regulatory and quality standards Desired Candidate Profile: 4 to 10 years of hands-on experience in formulation development in a regulated pharmaceutical environment. Experience in development of oral solid dosage forms or injectables preferred. Familiarity with QbD principles and regulatory requirements. Good documentation practices and communication skills. Ability to work independently and in a team environment. Interested Candidates, please share your cv to nazrin.rasheed@gracure.com
Posted 3 weeks ago
11.0 - 14.0 years
16 - 20 Lacs
Noida
Work from Office
Responsible for managing & operating all testing Labs & achieving revenue from all labs as defined by the management Responsible for implementation of quality policy throughout the labs Reviewing the contracts for new test methods as per the company norms Effective coordination with internal teams and other operational department or labs Ensures all lab staff have adequate resources to perform all aspects of work required Ensures all lab staff are adequately trained to safely perform all required job functions and that competency records are maintained Ensures corporate policy & procedures in the laboratory Provides employee motivation and champions the quality system, including, calibrations, quality assurance, training and lab quality system. Maintains an open door policy and communicates with lab staff to promote empowerment and accountability Obtains and maintains an in-depth knowledge of local market requirements Understands customer requirements and organizes lab procedures, schedules and staffing to provide for meeting/exceeding same Handles required disciplinary matters in a fair and consistent manner and maintains open communication with the all the departments Represents Spectro by appearance and conduct with strong ethical attitude Ensures laboratory practices meet or exceed company policy and industry standards Reads, understands and enforces the company quality and safety measures May on occasion be required to perform the duties of the lab supervisor and/or lab technicians Establishes or adjusts work schedules to meet testing requirements and control costs Markets actively for new clients Other duties as may be assigned by higher management Qualifications M.Sc/Phd/B.Tech Minimum 10 to 15 years of experience in managing Lab operations from NABL accredited testing company or testing labs
Posted 3 weeks ago
6.0 - 10.0 years
6 - 10 Lacs
Gurugram
Work from Office
Key Responsibilities: Lead cross-functional project management activities across Quality, Regulatory, different R&D ancillary functions, and manufacturing sites. Be a bridge between development teams, QA, RA, and other key departments. Coordinate development and tech transfer projects and ensure timely completion of tasks. Identify and resolve plant/site-related issues efficiently. Ensure project timelines and quality standards are met. Ideal Candidate Profile: 6-10 years of relevant experience in pharma project management. Strong communication and stakeholder management skills. Proven ability to multitask and drive teams towards results. Relevant technical exposure to QA/RA/R&D functions is highly desirable. Experience in tech transfer will be an added advantage. Education PG: M. Pharmacy in Any Specialization Interested Candidates can share their resumes on shikha.mishra@walterbushnell.com
Posted 3 weeks ago
3.0 - 7.0 years
5 - 10 Lacs
Udaipur
Work from Office
Position Purpose The role holder is responsible for working at the bench ensuring clear and on time delivery of products as planned by the department. This person should be responsible for developing formulations of different actives under the guidance of the Team Leader. The incumbent should be either a M.Sc./MTech/Ph.D. in any branch of chemistry (physical, analytical, agrochemicals, bio-technology). A few years hands-on experience in any organization is an advantage. Key Responsibilities: Strategic Actively imbibing the values and philosophy of PI Industries Efficient contribution to the overall success of R&D Chemistry by driving innovation and team performance according to objectives and targets being set by the Director and Head of Chemistry. Fulfilling requirements as set by Group Leader and Team Leader, e. g. within specific Research Projects Ensuring the security of intellectual property for R&D (patent applications, ensuring freedom-to-operate) Updating self with respect to formulation development and techniques, with special focus on agrochemistry Support the Team Leader with special focus on target setting and constantly seek functional feedback Operational Make and Test different formulations as advised by superior Compare the abovementioned products with other standards/market products Record and keep track of data generated Record all data and findings in ELN Participate in divisional meetings Other Responsibilities Maintain compliance under ISO/EHS/Safety norms Process Improvements Learn operation of various equipment under supervision Use the above learning to improve on product processing and lower batch cycle time Use the above to improve on shelf life of products People Cooperate with other team members on a daily basis Get and Give support as and when required and requested Audits & Compliance Ensure adherence to all policies and procedures
Posted 3 weeks ago
3.0 - 8.0 years
3 - 8 Lacs
Hyderabad
Work from Office
Dear Respect Applicants. Greeting from Biophore India pharmaceutical Pvt Ltd. (oral solution exp) or Inject able We have opening for Formulation R&D Department. 1) Candidate must have knowledge Prototype & Product Development. 2) Must have Literature Search. 3) Scale-up Batches, Exhibit Batches, DOE Experiments. 4) PDR Preparation & Development related documentation. 5) Experience in US ,EU Markets. 6) Preparation of documents form development stage to Technology Transfer Stage. Preparation and Review of SOP,S related to formulation R&D. 7) Good Communication Skills. Role & responsibilities Ref to Friends or colleagues Please share me update resume: careers@biophore.com Total Exp : Current CTC: Exp CTC: Notice Period: Current Designation:
Posted 3 weeks ago
2.0 - 5.0 years
4 - 7 Lacs
Mumbai, Tarapur, Ahmedabad
Work from Office
Kamla Homes is looking for Officer - Sterile Ointment to join our dynamic team and embark on a rewarding career journey Oversee sterile ointment production in cleanroom settings Monitor batch records and ensure GMP compliance Perform in-process checks and manage documentation Ensure safety and quality in operations
Posted 3 weeks ago
5.0 - 7.0 years
7 - 9 Lacs
Mumbai
Work from Office
Division IPD Department IPD Employment Type Permanent Job Purpose Execute the Formulation Technology Transfer activities across all Cipla sites & CMO to standardize, strengthen and improve the technology transfer processes and systems in line with regulations Accountabilities I. Conduct effective transfer of knowledge about the product and process to formulations manufacturing unit with required documentation for successful implementation of new product technology II. Identify and list requirements and prerequisites (RM, PM, tooling, accessories, machines, etc.) for execution of batches as per monthly rolling plan III. Participate in execution of placebo, feasibility, assessment, regulatory and amendment batches within defined timeframe IV. Gather and collate batch, process, in-process, physical, analytical and stability data for dossier compilation V. Assist in evaluation and extrapolation of acquired batch data during the transfer process, to define control strategy for commercial launch VI. Extend technical support to implement CIP, AVD and site transfer activities to drive product life cycle management for sustained growth VII. Participate in Tech Transfer activities at CMO for new products Education Qualification B.Pharm/ M.Pharm Relevant Work Experience 5-7 years of experience in formulation development and /or manufacturing, having knowledge of regulatory market Competencies/Skills Collaborate to Succeed Innovate to Excel Perform with Accountability Lead with Empathy Act with Agility Strong Domain Knowledge People Management Job Location Vikhroli Shift Hours
Posted 3 weeks ago
3.0 - 5.0 years
3 - 5 Lacs
Mumbai Suburban
Work from Office
Job Title/Description: Associate MPD Process AMA PHC, BB Duration: 1 year in the beginning [ basis business need & performance may be continued further] Required Qualification & experience: M. pharm. Pharmaceutics Location: GOA, Mumbai Note: Third Party Payroll Job - Ashkom Media India Pvt LTD. Required Skills: Work Experience: 3 - 5 years in pharmaceutical Formulation development + Technology Transfer. Formulation development + stability study management Roles: To assist in making QC Soft entries for report generation of various stability results compilations, Raw material samples co-ordination, protocol, report review To support to MPD Process/ADL technical team in making batch records & other MPD Technical documentation To support in indent, receive of raw material and analysis at MPD Goa lab. To support MPD - Process Team in Enovia Technical specification data management To assist in reviewing of various technical documents (e.g. PV Protocol- Reports, TT, MFR) of which draft is shared by respective project leader of MPD To assist the team in raising purchase request in Coupa software. To participate in other tasks i.e. Office administrative task assigned by MPD-GO Mumbai 8) To Help MPD Process technical team members in Change control management, Department SOP review, issuance management Responsibilities To raise Change control in Veeva GTRAQ QA system for MPD depts. in scope CCPs. Scope- CCPS to be raised for MPD teams located at different locations PAN India) To maintain track of on-going/work in progress CCPs /closer of change controls To keep track of timely completion of action items (In scope- CCPs raised by MPD )& to maintain action log of work completed/ongoing & pending action items. Support to MPD Process/ADL technical team in making batch records & other MPD documentation. QC Soft entries for report generation of various stability, Raw material samples, protocol printing. Supporting MPD/ADL Team at Goa (through email & Team space, common folders) for Sending samples for outside testing with proper documentation To participate in other tasks assigned by MPD- team members e.g., TT document review Supplier qualification technical document review, To liaison with RM suppliers for receipt of material qualification document, safety document & its review. Warm Regards, ______________________________________ "Your Manpower Managers" Varun Shrivas Executive - TA | HR ASHKOM MEDIA INDIA PVT. LTD. (An ISO 9001:2015 Certified Company) "Ashkom House" Dk -2/6 , Danish Kunj, Kolar Road Bhopal Pin code - 462042 Madhya Pradesh Mobile : +91-6262600059 / 8989271488 Website: www.ashkom.com
Posted 3 weeks ago
2.0 - 3.0 years
0 - 1 Lacs
Mumbai
Work from Office
Management Associate to be outsourced from M/s Ashkom A] Required No. of resources: 1 No B] Job Title/Description: Associate MPD Process AMA PHC, BB C] Responsibilities: Refer the highlighted below [ additionally, refer Screen shot shared earlier under - General : Key Accountabilities] 1) To raise Change control in Veeva GTRAQ QA system for MPD depts. in scope CCPs. Scope- CCPS to be raised for MPD teams located at different locations PAN India) 2) To maintain track of on-going/work in progress CCPs /closer of change controls 3) To keep track of timely completion of action items (In scope- CCPs raised by MPD )& to maintain action log of work completed/ongoing & pending action items. 4) Support to MPD Process/ADL technical team in making batch records & other MPD documentation. 5) QC Soft entries for report generation of various stability, Raw material samples, protocol printing. 6) Supporting MPD/ADL Team at Goa (through email & Team space, common folders) for - Sending samples for outside testing with proper documentation 7) To participate in other tasks assigned by MPD- team members e.g., TT document review 8) Supplier qualification technical document review, 9) To liaison with RM suppliers for receipt of material qualification document, safety document & its review.
Posted 3 weeks ago
2.0 - 3.0 years
0 - 1 Lacs
Mumbai
Work from Office
Subject: P&G Requirement- Management Associate to be outsourced from M/s Ashkom A] Required No. of resources: 1 No B] Job Title/Description: Associate MPD Process AMA PHC, BB C] Responsibilities: Refer the highlighted below [ additionally, refer Screen shot shared earlier under - General : Key Accountabilities] 1) To raise Change control in Veeva GTRAQ QA system for MPD depts. in scope CCPs. Scope- CCPS to be raised for MPD teams located at different locations PAN India) 2) To maintain track of on-going/work in progress CCPs /closer of change controls 3) To keep track of timely completion of action items (In scope- CCPs raised by MPD )& to maintain action log of work completed/ongoing & pending action items. 4) Support to MPD Process/ADL technical team in making batch records & other MPD documentation. 5) QC Soft entries for report generation of various stability, Raw material samples, protocol printing. 6) Supporting MPD/ADL Team at Goa (through email & Team space, common folders) for - Sending samples for outside testing with proper documentation 7) To participate in other tasks assigned by MPD- team members e.g., TT document review 8) Supplier qualification technical document review, 9) To liaison with RM suppliers for receipt of material qualification document, safety document & its review. D] Duration: 1 year in the beginning [ basis business need & performance may be continued further] E] Required Qualification & experience: M. pharm. Pharmaceutics F] Work Experience: 2.5 -3.5 years in the pharmaceutical Formulation development + Technology Transfer. Formulation development + stability study managment
Posted 3 weeks ago
3.0 - 5.0 years
3 - 5 Lacs
Mumbai Suburban
Work from Office
Job Title/Description: Associate MPD Process AMA PHC, BB Duration: 1 year in the beginning [ basis business need & performance may be continued further] Required Qualification & experience: M. pharm. Pharmaceutics Location: GOA, Mumbai Note: Third Party Payroll Job - Ashkom Media India Pvt LTD. Required Skills: Work Experience: 3 - 5 years in pharmaceutical Formulation development + Technology Transfer. Formulation development + stability study management Roles: To assist in making QC Soft entries for report generation of various stability results compilations, Raw material samples co-ordination, protocol, report review To support to MPD Process/ADL technical team in making batch records & other MPD Technical documentation To support in indent, receive of raw material and analysis at MPD Goa lab. To support MPD - Process Team in Enovia Technical specification data management To assist in reviewing of various technical documents (e.g. PV Protocol- Reports, TT, MFR) of which draft is shared by respective project leader of MPD To assist the team in raising purchase request in Coupa software. To participate in other tasks i.e. Office administrative task assigned by MPD-GO Mumbai 8) To Help MPD Process technical team members in Change control management, Department SOP review, issuance management Responsibilities To raise Change control in Veeva GTRAQ QA system for MPD depts. in scope CCPs. Scope- CCPS to be raised for MPD teams located at different locations PAN India) To maintain track of on-going/work in progress CCPs /closer of change controls To keep track of timely completion of action items (In scope- CCPs raised by MPD )& to maintain action log of work completed/ongoing & pending action items. Support to MPD Process/ADL technical team in making batch records & other MPD documentation. QC Soft entries for report generation of various stability, Raw material samples, protocol printing. Supporting MPD/ADL Team at Goa (through email & Team space, common folders) for Sending samples for outside testing with proper documentation To participate in other tasks assigned by MPD- team members e.g., TT document review Supplier qualification technical document review, To liaison with RM suppliers for receipt of material qualification document, safety document & its review. Warm Regards, ______________________________________ "Your Manpower Managers" Varun Shrivas Executive - TA | HR ASHKOM MEDIA INDIA PVT. LTD. (An ISO 9001:2015 Certified Company) "Ashkom House" Dk -2/6 , Danish Kunj, Kolar Road Bhopal Pin code - 462042 Madhya Pradesh Mobile : +91-6262600059 / 8989271488 Website: www.ashkom.com
Posted 3 weeks ago
3.0 - 6.0 years
10 - 20 Lacs
Hyderabad
Work from Office
Job Summary We are seeking a dynamic and experienced Formulation Scientist in Topical division for designing and development of formulation process, ensuring quality by design (QbD) implementation, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer. Roles & Responsibilities You will be responsible for end to end Formulation development of Topical formulations (Creams, Ointment, Gels, Sprays and Foams) including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effectiveProof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD). You will be responsible to support in scale-up to pilot/plant scales for topicals. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technologytransfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization,processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documentsfor drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materialsand ensure development studies are performed related to regulatory and internal system requirements. you will be responsible on preparation of assessments for impurities including Nitrosamine impurities and should be well versed with guidelines of India market, Russia market and US market requirements. Qualification Educational qualification: Masters in Pharmaceutical Technology/Pharmaceutics Minimum work experience: Approx. 5 years of experience in pharmaceutical company topical products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in Topical dosage forms Experience in areas of product development for Generic topical dosage forms Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Posted 3 weeks ago
5.0 - 7.0 years
8 - 10 Lacs
Dera Bassi
Work from Office
Roles and Responsibilities: Product Development : Lead and oversee the development of innovative nutraceutical and herbal formulations. Ensure compliance with customer specifications and industry standards. Process Optimization: Identify and implement improvements in manufacturing processes for efficiency and quality. Troubleshoot product or process issues during development and production. Regulatory Compliance: Ensure products and processes comply with regulatory requirements (e.g., FSSAI, AYUSH, etc.). Prepare and review technical documentation, such as dossiers, for domestic and international markets. Team Management: Supervise and mentor the R&D team, ensuring alignment with company goals. Collaborate with cross-functional teams such as production, quality, and marketing. Client Interaction: Engage with B2B clients to understand requirements and provide technical support. Develop customized solutions for client needs and ensure timely delivery. Market Trends & Innovation : Stay updated on global nutraceutical and herbal trends, technologies, and research. Drive innovation by introducing new ingredients, formulations, or technologies. Education : Master's or Ph.D. in Pharmaceuticals, Biotechnology, Food Science, or related fields. Experience : Min 5 year Salary : Rs. 60,000 per month to 80,000 per month (Depending upon the experience and interview) Working Hours: 8 Hours a day (6 days a week) Job Location : Dera Bassi, Punjab Day Off : Sunday Skills Required: Minimum 5 years in R&D within the nutraceuticals or herbal manufacturing industry. Strong understanding of herbal extracts, nutraceutical ingredients, and formulation science. Proven experience in B2B contract manufacturing setups.
Posted 3 weeks ago
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