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4.0 - 9.0 years
4 - 9 Lacs
Hyderabad
Work from Office
Handling of all Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across R&D, API and Formulation units of Biological E, pharma divisions. To perform On-site audits as part of vendor audits, contract testing laboratories, contract manufacturing, external service vendors qualifications. Initiation and Review of Quality Management Systems (QMS), including Change controls, Deviations, Investigation reports and CAPAs. To perform Risk assessments related to Vendor, Contract Testing Laboratories and Contract Manufacturing and Service Provider qualification related activities. Preparation & review of Quality agreements & Technical agreements. To provide support / relevant information to the customers / suppliers as per the requirement and to provide remediation plans for the audit observations, if any To schedule, perform the self-inspections and review the Self-Inspection reports and relevant documents as applicable. To facilitate and review the performance of quality system through the review of QMS documents for Management Review Meetings. To co-ordinate for Management Review Meetings. To review and monitor the effectiveness of system changes and adequacy of CAPAs and post closure effectiveness checks. To track the health authorities observations at the Site and R&D and verify the compliance. To coordinate with the team for preparation and implementation of SOPs pertaining to Corporate Quality.
Posted 1 month ago
3.0 - 6.0 years
3 - 7 Lacs
Surat
Work from Office
Proficient in Liquid, HTML, CSS, JavaScript, and Shopify APIs with expertise in theme and app Customization Design and develop high-performance Shopify stores tailored to client needs. Strong leadership skills with the ability to manage teams, take ownership, and deliver projects on time. Optimize speed, responsiveness, and overall user experience. Perform QA testing, fix bugs, and integrate third-party tools and secure payment gateways. Collaborate with teams to ensure store security, performance, and seamless functionality.
Posted 1 month ago
6.0 - 8.0 years
7 - 9 Lacs
Ahmedabad
Work from Office
Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formulation stability reports. Ensure compliance with regulatory documents and company quality standards. Coordinate with Analytical, Regulatory, Stores, Purchase, Project management and Development Quality Assurance teams to support product development and regulatory submissions. Maintain laboratory equipment and ensure proper calibration and maintenance. Participate in technology transfer activities to manufacturing sites. Prepare FD lab for agency audits and customer visits. Other roles and responsibilities assigned by the FD Manager and R&D Head. Preferred candidate profile Master's degree in Pharma or related field Must have 06 - 08 years of Experience in Formulation Development Must have 04 - 06 years of team handling role in R&D Centre
Posted 1 month ago
0.0 - 5.0 years
0 - 3 Lacs
Sanand, Ahmedabad
Work from Office
Department : Production Sciences or Pharmacy Graduates (M.Sc. / B. Pharm. / M. Pharm.) with 1 to 6 years Experiences in parenteral manufacturing (vial / ampoules / bottles of glass or Plastic through BFS technology). Candidate worked in production compliances / remediation / and having experiences of managing quality system document (CCN / CAPA / investigation etc.) Note : We also invite CV for various position in Production, QA, QC, F&D & Maintenance kindly forward the same to E Mail : rajeshthakor@aculife.co.in’
Posted 1 month ago
6.0 - 11.0 years
6 - 16 Lacs
Ahmedabad
Work from Office
Amneal is coming in your city Hyderabad this 07th & 08th Jun 2025 for Walk In Drive Hiring for Projects & Engineering and Peptide expereince : Walk-In Interview Drive #Hyderabad We are coming to your city for a walk-in interview drive! If you're looking to build a rewarding career with a growing Global Pharmaceutical Company, dont miss this opportunity. Day 1: Saturday, 07th June 2025 Time: 9:00 AM to 5:00 PM Venue: Lemon Tree Premier Plot No. 2, Survey No. 64, HITEC City, Madhapur, Hyderabad 500081, Telangana Day 2: Sunday, 08th June 2025 Time: 9:00 AM to 5:00 PM Venue: Vivanta Hyderabad, Begumpet 1-10-147 & 148, Mayuri Marg, Begumpet, Hyderabad 500016, Telangana Opening in Engineering Department for the following opening : Designation : Sr Executive / Manager Yrs of Exp : 5-12 Yrs Qualification : M.Tech / B.E Expereince into Electrical : Experienced in electrical project execution, compliance, and commissioning, with strong knowledge of HT and LT electrical systems and a solid understanding of pharmaceutical equipment requirements. Expereince into Instrumentation Skilled in automation and instrumentation of equipment and utility systems, with hands-on experience in regulatory compliance, calibration, temperature mapping, and thermal validation. Expereince into Civil Civil engineer overseeing site execution, quality assurance, regulatory compliance, cross-functional coordination, and project documentation in pharmaceutical projects. Expereince into Mechanical Mechanical project scope includes HVAC systems, utility services, regulatory compliance, project timelines, and cross-functional coordination. In-depth knowledge of process equipment used in injectable pharmaceutical plants experience in the installation, commissioning, and qualification of water systems. Expereince into Process Strong expertise in equipment used for injectable manufacturing, with preferable knowledge of isolator systems. Experienced in the installation, commissioning, qualification, and documentation of process equipment Interested candidates who are unable to attend interview, can share their CV on below mentioned Email Id with subject line Application for Falcon indiacareers@amneal.com
Posted 1 month ago
0.0 - 5.0 years
0 - 0 Lacs
Navi Mumbai, Pune, Mumbai (All Areas)
Work from Office
To offer consultation & patient diagnosis, perform/supervise all medical procedures of Dermat Led services ensuring efficacy, safety & high professional standards of medical procedures carried out under your supervision. Required Candidate profile Consultation & Patient Diagnosis Perform doctor led services Candidate must be MD or DVD or DDV or DNB in Dermatology Perks and benefits Leaves & Incentives as per company policy
Posted 1 month ago
4.0 - 6.0 years
5 - 7 Lacs
Ahmedabad
Work from Office
Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (No Objection Certificates) for imported pharmaceutical products. Regulatory Strategy: Provide strategic input on regulatory requirements for new product development, lifecycle management and post-market activities, including regulatory intelligence gathering and competitive landscape analysis. Cross Functional Collaboration: Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing teams to ensure alignment with regulatory strategies and compliance. Regulatory Health Authority Communication: Act as a liaison between the company and regulatory agencies to address questions or requests regarding regulatory fillings and approvals. Documentation and Reporting: Maintain accurate and up-to-date records of regulatory agencies submissions, communications with regulatory authorities and product approval status. Regulatory Training: Assist in training internal teams on regulatory requirements and best practices to ensure overall compliance across departments. Audit and Inspection Management: Coordinate with regulatory bodies in the event of audits, inspections or investigations. Preferred candidate profile Education: Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry or related field). Advanced degrees (e.g. Master's or Ph.D.) are a plus. Experience: Minimum 05 -07 Years of experience in Regulatory Affairs, with a focus on regulatory submissions and drug licensing in the pharmaceutical industries. Knowledge: In-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) drug development processes and regulatory submission strategies.
Posted 1 month ago
5.0 - 9.0 years
6 - 9 Lacs
Pune
Work from Office
Role & responsibilities To generate the correct EPLAN drawings. To deliver the correct bill of material and E-plan drawing as per schedule Study & Understand the new project from P&ID and Order Confirmation Interact with customer along with project / sales team to understand the customer needs by visiting customer location Understand scope of the project as per the inputs from Order by participating Kickoff meetings Analyze and extract the required inputs for automation from Engineering department Understand the final process/out come at customer end from Process Engineering department According to inputs prepare electrical drawings by using E-plan software Preferred candidate profile Must have experience of Sterile/ Injectibles/ Biopharma division. Hands on Experience on EPLAN Knowledge of AutoCAD software
Posted 1 month ago
6.0 - 9.0 years
7 - 10 Lacs
Pune
Work from Office
Role & responsibilities 1. Study& Understand of Project from P&I Diagram & Functional Specification Document. 2. Development Of Siemens PLC& WinCC SCADA or Rockwell PLC and SCADA. 3. Testing & Deliver PLC & SCADA program with quality & accuracy w.r.t. Functional Specification. 4. Co-ordination across cross fucntional team like QA,Process,Engineering,Factory. 5. Participating project kick-off , Internal FAT & customer FAT. 6. Site visit for commissioning. 7. Compliance of customer queries at the time Of FAT. Preferred candidate profile Must have experience of Sterile/ Injectibles/ Biopharma division.
Posted 1 month ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive For Production Injectables In Formulation Division @ Bollaram Department:- Production Injectables Qualification :-ITI | BA | Diploma | B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Skills :- LYO operator | Packing | Packing (Labelling) | Vial Filling & sealing | Compounding | QMS & Documentations | Autoclave | Aseptic processing area | Vial washing & Tunnel | Filling Division :- Formulation Interview Date:- 08-06-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- MSNF-II , Kothur | MSNF-V, Rk Puram Venue Location:- Plot No- 42, Anrich Industrial Estate, Bollaram Village, Hyderabad, Telangana 502325 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Lyo, Compounding, Autoclave,Vial Filling, Vial Washing, Sealing,Aseptic Processing Area, Tunnels, Labelling, About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 1 month ago
4.0 - 8.0 years
7 - 9 Lacs
Pune
Work from Office
Role & responsibilities Formulation development of Injectable FORMULATION for regulated market, USA and Europe. To carry out product development trials, process optimization trials, scale up trials and exhibit batches at manufacturing plant. Literature search of new products, to conduct pre formulation studies, other studies like Tubing studies, compatibility studies and filter studies. Preparation of development protocols, QbD/Risk assessment documents, technology transfer documents and product development reports. Ability to carry out investigations, troubleshooting exercises related to development, scale up and exhibit batches. Preferred experience on Lyo product and colloidal Iron product development.
Posted 1 month ago
18.0 - 28.0 years
20 - 35 Lacs
Halol
Work from Office
Sterile Operations Trainer Grade: G8 Designation: Deputy General Manager Location: Halol 1 Job Description: Education: B. Pharm / M. Pharm Overall responsibility of Aseptic Training Academy (ATA), Baska To plan, develop, and execute training at Aseptic Training Academy (ATA) - Sterile Operations for Sun Global Operations (SGO) Training. Creation of simplified training modules for technicians, scheduling and execution of training Creation of training evaluation and/or feedback systems Course creation according to levels (Level 1 - Technicians, Level 2 - Supervisors and above, Level 3 - Managers and above) pertaining to sterile operations Planning, scheduling & execution of technical training program relevant to sterile operations for new recruits/for existing employee by self/internal or external facility Identification of Certified trainer at various locations (sterile operations) based on additional training need of respective location Coordination with location head and Subject Matter Expert (SME) for conducting the additional training program according to training calendar on monthly basis pertaining to sterile operations To prepare and submit SGO training score card for sterile operations on monthly basis after plant review to Corporate Quality Policy and Training department (CQPT) To maintain the training records of training Periodical review of technical courses along with business units for site specific course and the head of course for suitable course content / design and pedagogy up gradation To coordinate in technical course scheduling and publishing of calendars and facilitate visiting faculty/guest faculty in course delivery Any other work assigned by superiors from time to time
Posted 1 month ago
4.0 - 9.0 years
5 - 8 Lacs
Amritsar
Remote
Role & responsibilities: : Sales Management Team/Channel management Customer Relationship Management Market Development Compliance and Reporting Budget and Resource Management Preferred candidate profile: : Leadership: Strong ability to manage, motivate, and develop a team of sales professionals at channel partner's level. Communication Skills: Excellent verbal and written communication skills, with the ability to present to clients and senior management. Industry Knowledge: In-depth knowledge of the pharmaceutical industry, Contrast media portfolio is definitely a value addition. Analytical Skills: Strong ability to analyze sales data, identify trends, and make data-driven decisions. Travel: Willingness to travel frequently within the assigned region Perks and benefits: :
Posted 1 month ago
0.0 - 5.0 years
12 - 18 Lacs
Kochi, Chennai, Bengaluru
Work from Office
Excellent scope for both (Fresher & Experienced Dermatologist) to offer client consultation, supervise and execute advanced skin & hair cosmetic procedures at the clinic. Responsibilities & Duties: Consult with and treat patients at the designated clinic, perform all dermatology-led medical procedures, and supervise non-dermatology-led procedures. Ensure the efficacy, safety, and adherence to high professional standards for all medical procedures performed under your supervision. Deliver treatments of the highest quality, following established SOPs and company guidelines. Strive for high client satisfaction in all consultations and treatments, as reflected by client feedback and evaluations from the Area Medical Head (AMH) and Area Operations Manager (AOM). Required Candidate profile: MBBS and Masters (MDDVL), Diploma (DDVL, DVD) or Doctorate (DNB) in Dermatology. Strong knowledge and experience in medicine and dermatology. Excellent communication skills and Energy Levels. Ability to connect well with clients. For more details contact 9908974287 or amulya.doni@olivaclinic.com
Posted 1 month ago
4.0 - 6.0 years
0 - 2 Lacs
Hyderabad
Work from Office
Role & responsibilities JOB SUMMARY In line with business strategy, develop and introduce new packaging solutions that satisfy the consumer, customer • Work closely with the cross-functional teams in order to effectively deliver new, fit for use packaging solutions to the business. • To support the Product Development and Process Managers throughout the launch procedure. KEY ACCOUNTIBILITIES % OF TIME Packaging Development Awareness of new briefs and critical path requirements. Assist with internal feasibility assessment. Provide packaging solutions for new products, range re-launches and range extensions/Alternate vendor developments. Generate and manage the packaging critical path in conjunction with the Development and Process Managers. Be involved in the appropriate phases to ensure the correct management of the packaging process as the product moves from Concept to Launch. Provision of all information in order for concept team to finalise product costings. Work with the Process team on pre-production runs, ensuring customer approval of packaging. Where appropriate conduct alternative supplier evaluation trials Follow risk management procedures. Review of transit trials with the process team Basic packaging specification management, including checking the quality of information. Ensure that all packaging for new products meets with customer and business expectations whilst adhering to legislative, quality, safety, and environmental standards. Ensure all packaging for new products achieves manufacturing performance by providing cost effective solutions. Management of packaging samples throughout the process for the new development products. Strongly influence and shape the customers perception of the company as a forward thinking innovator with regards to packaging. Proactively investigate innovative and new packaging solutions for new and existing product. Take the lead in developing and promoting new packaging innovation. Identify and visit new potential suppliers that can help us achieve our goals of excellence in packaging innovation. Sourcing and finalization of Primary packing materials for R&D and commercial in a regulated market. Knowledge of sourcing of Vials, stoppers, PFS, auto injectors, pens, bags, tubes and films, primary filters and secondary filters, ophthalmic 3-piece containers, Tubing for filling lines , seals, Labels, cartons aluminum pouches Vendor related documents to ensure the vendor qualification and their manufacturing facility audits. Business continuity plan/derisking plan for the complex development products. KEY ACCOUNTIBILITIES % OF TIME KSM/Raw material procurement/Advance intermediate/Chemicals . The person should have minimum understanding in procuring of the API related raw materials like : KSM/Raw material procurement/Advance intermediate/Chemicals. . should have understanding about regulatory requirement of KSM/Raw material procurement/Advance intermediate/Chemicals vendors to manufacturer an API and its regulatory filing requirements.
Posted 2 months ago
18.0 - 25.0 years
40 - 60 Lacs
Bengaluru
Work from Office
Off Targets is a leader in pharmaceutical innovation, committed to developing advanced therapeutic solutions that address unmet medical needs. We are looking for an experienced and dynamic professional to lead our Formulation Development department, driving the development of cutting-edge injectable drug products. Job Description We are seeking an accomplished R&D leader to head our Injectable Formulation Development function. The ideal candidate will bring deep technical expertise in complex injectable products and a strategic mindset aligned with 505(b)(2) development, regulatory planning, and IP differentiation. Key Responsibilities: Lead end-to-end formulation development of complex injectable drug products (liposomes, emulsions, depot injections, suspensions, etc.). Design and drive a robust R&D pipeline focused on 505(b)(2) opportunities . Provide strategic input into USFDA regulatory planning (CMC sections, QbD, stability). Contribute to patent strategy and product differentiation from early development. Collaborate with analytical, regulatory, IP, and business development functions. Mentor a high-performing R&D team and build scientific leadership. Solve scale-up and technology transfer challenges. Maintain strong compliance with global quality and documentation standards. Key Skills: Injectable Formulation, 505(b)(2), Liposomes, Emulsions, Depot Injections, Formulation R&D, CMC, USFDA, Drug Delivery, Intellectual Property, Team Leadership, Innovation Strategy Desired Candidate Profile: Qualification: Ph.D. / M.Pharm in Pharmaceutics or related field Experience: 15+ years in pharmaceutical R&D with at least 5 years in a strategic leadership role Proven expertise in injectable formulations and 505(b)(2) development Strong knowledge of USFDA CMC expectations, IP evaluation , and regulatory submission processes Excellent leadership, innovation, and cross-functional collaboration skills Perks and benefits Opportunity to lead a key department in a forward-thinking pharmaceutical company. A collaborative and supportive work environment that encourages professional growth and innovation. Competitive salary and benefits package, with opportunities for advancement. Access to state-of-the-art facilities and cutting-edge technology. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com
Posted 2 months ago
10.0 - 20.0 years
15 - 25 Lacs
Bengaluru
Work from Office
Job Description We are looking for an experienced and dynamic Team Leader to head our Analytical Research team within the Pharmaceutical R&D division, focused on complex injectable products and 505(b)(2) submissions . This role is ideal for a candidate with a strong background in pharmaceutical R&D , robust team management skills , and deep understanding of injectable formulation analytics . Key Responsibilities Lead and manage the analytical research team supporting complex injectable development. Supervise daily lab operations, resource allocation, and project timelines. Drive method development, validation, and troubleshooting for injectable formulations. Provide scientific leadership and ensure data quality and regulatory compliance. Maintain high team morale and cultivate a positive, collaborative work environment. Guide preparation of analytical documents for regulatory filings (505(b)(2), ANDA, etc.). Impart training, develop team capabilities, and mentor junior scientists. Collaborate closely with formulation, quality, and regulatory teams. Ensure compliance with cGMP, GLP, and internal SOPs. Desired Candidate Profile Qualification: M.Pharm / Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or related field. Experience: 8+ years in Pharmaceutical R&D , minimum 3 years in a leadership/supervisory role . Hands-on experience in analytical method development for complex injectables (liposomes, suspensions, emulsions, etc.). Sound knowledge of 505(b)(2) regulatory pathway . Strong command of analytical techniques: HPLC, GC, spectroscopy, particle size analysis, etc. Proven track record in team leadership, project coordination , and technical problem-solving . Excellent communication and interpersonal skills. Key Skills Analytical R&D, Complex Injectables, Injectable Formulations, Team Management, 505(b)(2), Method Development, HPLC, GC, Troubleshooting, Pharmaceutical R&D, Training & Mentoring
Posted 2 months ago
10.0 - 12.0 years
10 - 12 Lacs
Hyderabad
Work from Office
Role & responsibilities Job Title: MSAT - Technology Transfer Specialist (Injectables) Job Summary: The MSAT Technology Transfer Specialist for Injectables will be responsible for overseeing the transfer of injectable drug products from development to commercial manufacturing. This role requires close collaboration with cross-functional teams, including R&D, Quality, Manufacturing, and Engineering, to ensure a seamless transfer process, operational excellence, and compliance with cGMP regulations. Key Responsibilities: Technology Transfer Oversight: Lead and coordinate the transfer of injectable drug products from development to commercial production facilities. Ensure that all documentation, including protocols, procedures, and specifications, is complete and accurate during the transfer process. Collaborate with R&D and other departments to troubleshoot and resolve technical issues during the technology transfer. Cross-Functional Collaboration: Work closely with internal teams (Manufacturing, Engineering, Quality, and Regulatory Affairs) to ensure alignment and understanding of technical requirements during the transfer. Serve as a point of contact between the development team and the commercial manufacturing site, facilitating communication and ensuring a smooth transition. Process Development and Optimization: Provide technical expertise to optimize manufacturing processes for injectables. Identify and implement process improvements to enhance product yield, quality, and cost-effectiveness. Ensure that manufacturing processes are scalable, robust, and compliant with regulatory standards. Regulatory Compliance: Ensure that all aspects of the technology transfer process adhere to cGMP (current Good Manufacturing Practices) and regulatory requirements. Support regulatory submissions by providing necessary documentation and technical information as needed. Training and Knowledge Transfer: Develop and conduct training sessions for production personnel, ensuring that they are well-prepared for the commercial production of the injectable products. Transfer critical knowledge related to formulation, filling, and packaging processes to manufacturing teams. Process Validation: Lead and support process validation activities, ensuring that processes are qualified and validated in accordance with regulatory requirements. Oversee the creation, review, and approval of process validation protocols and reports. Problem Solving and Troubleshooting: Troubleshoot and resolve any issues that arise during the technology transfer and manufacturing processes. Apply scientific and technical knowledge to identify root causes and implement corrective and preventive actions. Continuous Improvement: Lead or support continuous improvement initiatives to enhance the efficiency, quality, and consistency of the injectable manufacturing processes. Support initiatives to reduce cycle times, improve yield, and minimize waste. Documentation and Reporting: Prepare and review required technical documentation, including batch records, validation protocols, and reports. Ensure timely and accurate reporting of technology transfer progress, challenges, and resolutions to senior management. Project Management: Manage the technology transfer timeline, ensuring all milestones are met within established deadlines. Monitor the progress of technology transfer activities, identify potential risks, and implement mitigation strategies to ensure successful completion. Qualifications: Education : Bachelors or master’s degree in engineering, Life Sciences, Chemistry, Pharmaceutical Sciences, or a related field. Experience : 5+ years of experience in technology transfer, manufacturing, or process development within the pharmaceutical industry, with a focus on injectables. Strong knowledge of cGMP and regulatory requirements for injectable drug products. Proven experience in process optimization, troubleshooting, and scaling up manufacturing processes. Experience with project management and cross-functional team collaboration. Skills: Strong technical understanding of injectable drug products, including formulation, filling, and packaging processes. Excellent communication, teamwork, and leadership skills. Proficient in technical documentation and report writing. Familiarity with Lean, Six Sigma, or other process improvement methodologies is a plus. Preferred candidate profile
Posted 2 months ago
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 2 months 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 2 months ago
4.0 - 9.0 years
4 - 7 Lacs
Gangtok
Work from Office
Process Mechanical, Process Electrical, HVAC, Water System with WFI Knowledge, Utility Electrical (Chiller, DG, Air compressor, Heat pump, Boiler)
Posted 2 months ago
4.0 - 9.0 years
4 - 9 Lacs
Nalagarh
Work from Office
Greetings from Immacule Lifescience Pvt. Ltd! We are seeking experienced professionals for multiple positions in our Engineering department at our sterile injectable formulations manufacturing plant located in Nalagarh, Himachal Pradesh. Department : Engineering - Sterile Formulations Experience : 4 - 8 years Qualification : B. Tech (Electrical & Instrumentation) / Diploma (Electrical & Instrumentation) Positions Available: Officer / Executive : Plant Maintenance Engineering Executive / Senior Executive : Engineering QMS (Quality Management System) Officer : Building Management System (BMS) & Environmental Management System (EMS) Key Requirements: For plant Maintenance & QMS Hands-on experience with injectable equipment, including: - Vial Washing Machine - Vial Filling Line - Tunnel - Autoclave - Pre-Filled Syringe (PFS) Machine - Strong understanding of engineering principles and practices in a sterile manufacturing environment. How to Apply: Interested candidates can send their updated resumes to Eswar.reddy@immacule.in
Posted 2 months 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 2 months ago
2.0 - 6.0 years
3 - 6 Lacs
Bengaluru
Work from Office
Production : Associate /Senior Associate Qualification : B. Pharmacy / M. Pharmacy Experience : 2 to 6 years Must have Injectable and Regulatory Knowledge in any of these areas: Aseptic processing activity (Vial/PFS), Bulk compounding, sterilization,Vial washing & Depyrogenation,Lyophilization & Terminal sterilization process. Infusion bags processing activities, In-process checks and Line Clearance activities, Handling of shift activities and manpower. Computer Proficiency: TW, Documentum , MES & SAP, GEP
Posted 2 months ago
3.0 - 7.0 years
4 - 9 Lacs
Bengaluru
Work from Office
Walk-In Drive Hyderabad | June 1, 2025 Join our growing team at OneSource The new way to CDMO We're hiring for multiple roles across our R&D and Manufacturing facilities in Bengaluru. Walk-In Interview Details: Date: Sunday, June 1, 2025 Time: 9:00 AM 4:00 PM Venue: Oakwood Residence, 115/1, Road No. 2, Financial District, Gachibowli, Hyderabad, Telangana 500032 Open Positions: Process Development Lab (Unit 1, Bommasandra) Research Associate | Sr. Research Associate | Scientist Qualification: B.Tech / M.Tech (Biotechnology) Experience: 2 – 12 years Drug Substance Manufacturing (Unit 2, Doddaballapura) Executive | Sr. Executive Qualification: MSc / B.Tech / M.Tech (Biotech, Microbiology) Experience: 2 – 8 years Drug Product Manufacturing (Unit 2, Doddaballapura) Executive | Sr. Executive | Team Leader Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm Experience: 2 – 12 years in sterile injectables
Posted 2 months ago
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