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8.0 - 13.0 years
10 - 20 Lacs
Ahmedabad
Work from Office
Summary Job Functions: Handling, supporting and executing all activities including training to subordinates for manufacturing process support and any late stage developmental work for process improvement related to Downstream process in MSAT. Key Responsibilities: - Execution of process scale up experiments, documentation and process improvements to support manufacturing. - Process transfer and execution of tech. transfer with help of BBM. - Planning and executing experiments of DSP for process improvement, demonstrating and recording the same in proper format / report. - Designing and execution of scale down experiments to support manufacturing for scale up. (Bag evaluation/Filter sizing/Alternate vendor evaluation etc.) - Drafting the process related reports, protocols and IOC as a part of documentation - Support of process transfers- Evaluation and support for implementation of new processes focusing on direct transfers - Preparation of Qualification /verification documents (Protocols and reports) of equipment Responsible for conducting experiments to support the manufacturing team in need for any issues or improvement in the process. Both for microbial and mammalian process - Responsible for providing shop floor support during scale up activities for engineering, CT and PPQ batches - Ensures corporate cGMP and GLP compliance of all activities performed. - To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site. - To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. - To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description.
Posted 1 week ago
15.0 - 18.0 years
15 - 20 Lacs
Bengaluru, Ramanagara
Work from Office
Role & responsibilities Dy.Manager / Manager Production Preferred candidate profile Responcible for Tablet Granulation, Coating & compression, Laser drilling machine , Responsible for sieve, screen, FBE finger bag inventory records, Should Have exposure with Exhibit batches, validation batches , Responsible for Production dept. and process improvement and development. Responsible for manufacturing of new products coordinating with R&D department. Resolve the Quality issues or any delay by coordinating with other departments. Preparation of Batch Manufacturing Record (BMR) from R&D guideline. Investigate the incidents and deviations in production area. Manpower handling and time management. should have process and cleaning validation activity in manufacturing area Good Knowledge about equipments like RMG , FBD, FBE, vibratory sifter, IPC Blender, Octagonal Blender, Multimill, Tray Dryer, steam kettle Good Knowledge about IQ, OQ and PQ of manufacturing area Should be master in Manpower handling and time management.
Posted 1 week ago
0.0 years
1 Lacs
Dahej
Work from Office
Role & responsibilities: Candidates will have to work on Apprenticeship Training for one year. If your performance is excellent we will consider you for permanent job role opportunity. Department: Formulation Technology Transfer Preferred candidate profile: Candidates should have the below mentioned % criteria: In 10th & 12th Candidate should have 60% aggregate or above of both the classes. Candidates should not have any kind of ATKT/Backlog throughout M. Pharm degree. Location: Dahej, Gujarat Stipend: Rs. 12,000 per month (Fixed) Interested candidates please share your updated CV's on hrdahej@torrentpharma.com.
Posted 4 weeks ago
3.0 - 8.0 years
2 - 7 Lacs
Dahej
Work from Office
Role & responsibilities: To receive instructions from AM / Manager / GM. To plan the work as per instructions from department head. To track the daily exhibit / site shift product's trail, engineering, Exhibit & Validation (not limited to) batches manufacturing and monitor it's progress constantly. To organize, supervise and control the activities of Technology Transfer department. To co-ordinate and co-operate with various departments like Raw material store, Engineering, Quality Assurance, Administration, Information Technology, Operational Project, Quality Control, Production etc. for smooth functioning of Technology Transfer department. To check and update various documents and records, ensure production records filled online during batch manufacturing. To check and maintain housekeeping of the department. To enforce latest developments in GMP, SOP's etc. To observe and report to the seniors of Product / Material / Machine for their abnormal identified behaviour during production process. To counter check Raw Materials Dispensing and to recheck the material prior to their use in production processes. To ensure that the Quality, Health, Safety, Environment policy and procedures are followed. To prepare documents of New Product (ANDA) and site shift products (which includes CCF, MFC, BMR, QFR, ISP, PPQP, QRM, ESR TT Protocol, TT Report & PPQR (not limited to). To prepare documents for MES activity. To check, (i) Sampling request to Quality Assurance Department (ii) Material requirements requisitions (iii) Received batch from RM department To check / verify, (i) Daily Work in progress status. To achieve required production targets as per the budgetary norms. Handling of change parts. To ensure proper follow of company's rules and regulations. To ensure that all documents are complete in all respect prior to next stage of processing. To write requisition slips of Auxiliary Materials / Stationary materials etc. of daily use. To procure and control the utilization of such materials. To maintain optimum stock level of such materials for smooth functioning of department. To carry out any additional responsibility entrusted from time to time. Monitoring of Production process at each stage. To understand and follow all written procedure and manufacturing instructions mentioned in the respective batch record or any other quality document before starting production activity. To monitor constantly the CAPA of deviations, OOT and OOS to complete within time frame. To perform the investigation within timeframe related to quality system i.e. deviation, OOT and OOS. To be in communication with TRC and it's cross functional team for coordination and knowledge sharing of new site transfer products. To ensure that all SOP trainings are fulfilled on periodic basis. To coordinate activities like visit, document transfer and monitoring (but not limited to) related to manufacturing of products at CMO site. Preferred candidate profile: Candidates should have experience in Pharmaceutical background. Qualification: M. PHARM. Experience: 3 to 8 Years
Posted 1 month ago
4.0 - 8.0 years
6 - 10 Lacs
Hyderabad
Work from Office
Role & responsibilities Job description Dosage forms experience: Solid Oral & Injectable experience in TTD/PDL/MS&T. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development in R&D and in Pilot/Manufacturing Site. Follow good laboratory practices, good documentation practices (LNB writing) and maintain the logbooks and forms for equipment/instruments. Dedicate Experience in technology transfer of product(s) under development activities from scale up, exhibit batches. To lead and support the site transfer products from scale up to product launch. To prepare, review and hand-over the Technology Transfer Dossier to plant and communicating effectively to CFT team :- MFR, MPR, BMR, BPR, Preliminary Risk assessment (as per QbD) Risk Assessment of before going to Scaleup Risk Assessment of before going to Exhibit batches Scaleup Protocol & reports Scaleup Sampling and Exhibit batch sampling Plan Exhibit batch reports Control Strategy (Qbd) before Scaleup, Exhibit batches Risk assessment of CPP over CQAs and etc. And not limited to. To provide the technical inputs for initiation of Scale up batches. To provide the technical presentation on new product initiation to Cross functional team. To monitoring and execution of Scale up batches for site transfer products as well as in-house developed products. To co-ordinate with cross functional teams for smooth technology transfer. To review the exhibit batch documents, intended documents for filing purpose. Qualifications M.Pharm or Ph.D. in Pharmacy with minimum industrial experience of 4 to 9 years in technology transfer solid oral formulations and injectable products.
Posted 1 month ago
3.0 - 8.0 years
3 - 7 Lacs
Ahmedabad
Work from Office
Great Opportunity to work with one of the fastest growing Pharmaceuticals in India!! About us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and affordable medicines across the nation. With more than 4 decades of medical service to society, Unison is today one of the fastest-growing companies in Gujarat State. In addition to this, the company is ranked 82 among the top companies of India (Rupee wise sales) MAT March 2020. This makes Unison a distinguished company across the pharma industry. We are expanding our team!! Looking for passionate Formulation Scientist - Technology Transfer - EU market at our dedicated R&D center. Department : Formulation Development - Technology Transfer Formulation : Solid Orals Market : Europe Experience Required : 4-7 years Designation : Sr. Officer / Executive / Sr. Executive Location : R&D Center, Moraiya, Ahmedabad (Transportation from specific route if Ahmedabad is provided) Roles & responsibilities (Not Limited to): Execution of Scale-up, exhibit batches, validation batches for Regulated market products Feasibility trial, evaluation, execution of commercial validation batches for site variation contract manufacturing projects Document preparation, review related to SU/EB and validation batches Perks & Benefits: Dynamic work environment Career development opportunities Work-life balance Free transportation Canteen facility Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical R&D and possess the required skills & experience, we encourage you to apply for this position. Interested one can revert with their resume on career@unisonpharmaceuticals.com Regards, Team HR
Posted 1 month ago
4.0 - 9.0 years
4 - 9 Lacs
Hyderabad
Work from Office
Dear Respected All, Greeting from Biophore India pharmaceutical Pvt Ltd. We have opening for Formulation R&D Department - oral solution exp or Injectable Experience : 2-10 Yrs Job Location: Pashamylaram - Patancheruv Job Description: Candidate must have knowledge-Literature Search, Product Development,Scale-up Batches, Characterization, Prototype Development, , Exhibit Batches, DOE Experiments , PDR Preparation & Development related documentation. Experience in US ,EU Markets .Preparation of documents form development stage to Technology Transfer Stage. Preparation and Review of SOP,S related to formulation R&D. Ref to Friends or colleagues Please share me update resume: careers@biophore.com Total Exp : Current C T C : Exp C T C : Notice Period: Current Designation:
Posted 1 month ago
4.0 - 9.0 years
4 - 9 Lacs
Hyderabad
Work from Office
Dear Respected All, Greeting from Biophore India pharmaceutical Pvt Ltd. We have opening for Formulation R&D Department - oral solution exp or Injectable Experience : 2-7 Yrs Job Location: Pashamylaram - Patancheruv-Sangareddy Dist. Job Description: Candidate must have knowledge-Literature Search, Product Development,Scale-up Batches, Characterization, Prototype Development, , Exhibit Batches, DOE Experiments , PDR Preparation & Development related documentation. Experience in US ,EU Markets .Preparation of documents form development stage to Technology Transfer Stage. Preparation and Review of SOP,S related to formulation R&D. Ref to Friends or colleagues Please share me update resume: careers@biophore.com Total Exp : Current C T C : Exp C T C : Notice Period: Current Designation:
Posted 1 month 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 1 month ago
8.0 - 12.0 years
9 - 12 Lacs
Thane, Mumbai (All Areas)
Work from Office
Role & responsibilities To lead the OSD department team and ensure manufacturing process development and Optimization as per the regulatory requirements & technology transfer of the projects in co-ordination with Production and planning department for regulatory & ROW products. Accountabilities and mandatory requirements: Ensure composition and manufacturing process development of new as well as established products and ability to improvise if needed. Ensure manufacturing process/new process within Budget for maximizing efficiencies of Formulation Department Lab. Guide group for day-to-day activities and informing Formulation Development Department (FRD) colleagues for the schedule and timelines for the product development as well as technology transfer of Exhibit, Validation or commercial batches. Ensure group co-ordinate with other functions including Purchase, Production for the status of availability of Raw Materials, Packaging Materials required for development batches/ exhibit batches/ Validation batches at site. Ensure development and stability data generation of the new as well as trouble shooting products as per the regulatory or ROW market requirements. Guide to the for encounter the trouble shooting of legacy products and to provide the Technology transfer documents to resolve or to overcome issues related to the legacy products to provide quality products to the customer. Guide group for the smooth technology transfer of new as well as existing products or trouble shoot products for better to meet the finished product specification. Ensure the Regulatory queries to be addressed in time and guide the group leaders to work on to provide comments on the received quires to be close within provided timeline. Work closely with cross functional team for planning /execution of the Technology transfer/Exhibit/Validation batches of the individual projects to meet the timelines assigned. Provide the technical oversight (guidance), Plan, co-ordinate and oversee the work activities related to technology transfer/Exhibit batches/Validation batches of projects not limited to EU authorization but also CMO/ROW projects. Ensure Compilation of Development batches/Exhibit batches/validation batches data included with critical observations and submission of the same to R&D Head. Co-ordinate with production department for planning of tech transfer /Exhibit/Validation batches and execution/monitoring of the batches of the products starting from dispensing of the materials till packaging of the product to ensure smooth technology transfer of the products complying to the regulatory requirements. Preferred candidate profile- - 8-12 years of experience in Regulated market- OSD formulation & Development and technology transfer. - Good communication, open exchange of information and project teamwork will be required in order to meet the job performance. - Will be expected to accomplish his work assignments by interacting closely with scientific staff/Production staff and by developing the co-operative working relationships with other personnel within the company. - Must be able to work/co-ordinate with different functions within ALS and prioritize the workload to meet the predetermined timelines and need to work as a team with open communication, transparency and mutual trust. - Proper documentation pertaining to Formulation Development as per the Regulatory requirements and as per companys system.
Posted 1 month ago
2 - 7 years
4 - 8 Lacs
Gandhinagar
Work from Office
Role & responsibilities • To receive and understand the technology from FnD dept. • To design optimisation for process parameters & participate in the trials at R&D. • To transfer the technology from R&D to receivers site for the respective product. • To monitor the TT demo / exhibit/scale up and optimization batches. • To review the technical information sheet, product detail, raw material/accessories/ equipment requirement for plant trial/SU/Exhibit batches. • To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements. • To get involved and observe in the TT demo batch with F&D. • To take scale up batch at manufacturing locations and prepare scale up batch protocol, Scale Up Reports, MFC, Sampling Protocol, Risk Assessment etc. • To take the exhibit batches at the manufacturing locations and take care for its trouble shooting. • To prepare the summary reports. • To perform investigation for Deviation/ OOS/ OOT observed during SU/EB at plant. To prepare agency query responses.
Posted 2 months ago
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