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4 - 9 years

5 - 12 Lacs

Dahej, Panaji, Mumbai

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Help in Day To Day Production Of Pharmaceutical Products Manpower Allocation For Smooth Working In Shift Supervision Of Production Activity BMR And BPR Report Preparation Data Preparation For Internal And External Audit -IE. US FDA - EU GMP Etc Required Candidate profile B. Pharm - M. Pharm - B.Sc - M. Sc Experience In Production Or Packaging Working Experience US FDA Approved Plant is Desirable FDA Approval in Tablet - Capsule Or Any will be an added advantage

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- 5 years

1 - 4 Lacs

Paonta Sahib, Chandigarh, Panchkula

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Role & responsibilities We are seeking a diligent and experienced QA & QC & production. The successful candidate will Ensure that our products meet specified quality standards. This role involves managing both Quality Assurance ( QA ) and Quality Control (QC) processes, conducting inspections, and implementing improvements to maintain and enhance product quality. Expanding role in building a team of QA/QC executives. Salary Range: 15,000 to 25,000 (negotiable based on experience & skills) Experience: Minimum 2 years in QA/QC department of Tablet & Capsule or pharma manufacturing unit Preferred candidate profile Quality control analyst Responsible for testing and analyzing pharmaceutical products to ensure they meet established quality standards. They work in laboratories, using analytical Techniques to test raw materials, in-process samples, and finished products. Quality assurance analyst Responsible for ensuring compliance with regulatory requirements by conducting audits, inspections, and assessments Preferred candidate profile Qualification B.Pharma , B.Sc or B.Tech Biotech D.Pharma DIKSHA ( 8628944666 ) (9:30 AM to 7:30 PM ) Preferred candidate profile Company - Top Pharmaceuticals Companies based at Baddi HP. Fresher & Experience. Job Location- Chanigarh,Panchkula, Paonta Sahib ,BADDI ( Himachal Pradesh ) Functional : QC,QA & Production.Industry: Pharma manufacturing unit/ Food Technology The Saksham Success Enterprises Near Sunder Ayan by pass solan 173212 Himachal Pradesh Contact us DIKSHA ( 8628944666 ) (9:30 AM to 7:30 PM )

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15 - 20 years

13 - 17 Lacs

Mumbai, Boisar, Palghar

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Role & responsibilities 1. Production Planning and Scheduling 2. Compliance and Documentation 3. Supervision of Manufacturing Processes 4. Personnel Management and Training 5. Quality and In-Process Control 7. Process Optimization and Yield Improvement 8. Regulatory and Customer Audits Preferred candidate profile Education: B.Pharm / M.Pharm / B.Sc with strong domain knowledge in OSD manufacturing. Experience: 15+ years in pharmaceutical production, with at least 5 years in a managerial role overseeing OSD manufacturing. Regulatory Exposure: Hands-on experience in facing WHO-GMP, and other inspections. Skills: Leadership, decision-making, analytical thinking, team management, and strong knowledge of GMP and QMS.

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10 - 20 years

5 - 15 Lacs

Greater Noida

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Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics and APIs, comprising Solid Dosage Formulations and Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research and Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it's a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R and D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL's full-fledged Regulatory Affairs and IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization.

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8 - 13 years

10 - 15 Lacs

Chennai

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We are looking for a Regulatory Affairs Professional for a leading pharmaceutical company based at Chennai location. Regulatory Affairs, RA ANDA, Product Lifecycle, Preparation & Submission, US Market, Formulation, Solid Orals or Injectables. Interested Candidates share your updated resume with srinidhi@bvrpc.com

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15 - 24 years

14 - 24 Lacs

Halol

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Position : Section Head - Batch Release QA Functional Area: QA Reports to: QA Head Grade: G9B Department: Quality Location: Halol (OSD) POSITION SUMMARY Responsible for IPQA activity and strategy in line with Sun Pharma Compliance, Product Quality Management objectives and Regulatory requirements. Responsible for planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or Procedures. Identify and implement solution for improving existing site quality assurance systems and processes Involvement in co-ordination of activities for software like SAP HANA at plant Responsible for review and Approval of Quality management/GMP records. Responsible to ensure and perform site data review of batch records for completeness of documentation, approval and rejection of materials per current good manufacturing procedures and escalation of quality incidences, Continuous process verification (CPV). Manage the batch release function at site wrt documentation, systems, approval and rejection of materials, products at the Site per current Good Manufacturing Practices requirements. The incumbent will assure individual compliance with the all concerned regulatory requirements, GxPs and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures. Key responsibilities: 1. Ensure compliance to regulatory requirements on product, process, equipment and release procedures. 2. Manage Batch release activities for commercial dispatch. 3. Escalate compliance concern to concern stakeholder. 4. Review, compliance of BPR and batch release for commercial dispatch. 5. Review and approve the investigations, CAPA, and effectiveness checks with adherence to timeline. 6. Execute change control and risk assessment whenever required. 7. Ensure Quality Metrics, Quarterly BPR report as per specify timeline. 8. Ensure timely Batch release through electronic system. 9. Planning and arranging for internal and external departmental support of Quality Assurance activities as directed in approved protocols, quality systems or Procedures. 10. Follow the EHS policy and maintain the compliance to GMP requirements. 11.Co-ordination with QPs and customers of different region for batch release. 12.Management of Technical agreement with QP and Customers. 13.Responsible for oversight in warehouse and BSR. 14.Management of retain sample storage , inspection and life cycle management. MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS M.sc / M. Pharm/ B. Pharm 15 years with work experience preferred. REQUIRED SUCCESS ATTRIBUTE Knowledge of GxPs, cGMP and other regulatory requirements. Planning and Prioritization Collaboration Accountability Compliance Customer Service orientation Secondary Success Attributes People Connect Attention to detail Emotional control Effective Communication & Problem solving WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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2 - 7 years

4 - 8 Lacs

Gandhinagar

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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.

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3 - 8 years

3 - 8 Lacs

Mumbai

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WALK -IN INTERVIEWS FOR FORMULATION SCIENTISTS ON 31ST MAY 2025 AT OUR R&D , KANDIVALI (W), MUMBAI. Designation : Research Associate / Research Scientist Department : Formulation & Development Qualification : M.pharma. / Ph.D. Experience : Candidates having 3 to 8 years experience in Product development of Solid Orals, Onco OSD, Liquid Orals and Sterile formulations. Markets handled: Regulated / ROW / Domestic. CARRY YOUR UPDATED RESUME & PASSPORT SIZE PHOTO AT THE TIME OF INTERVIEW.

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1 - 5 years

1 - 4 Lacs

Ahmedabad

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compliance with GMP and quality policie Approve RM/PM vendors and conduct regular quality audit validation, qualification, and batch release. GMP training $ support factory-wide implementation. Manage change control, deviation, and QMS execution.

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12 - 20 years

12 - 16 Lacs

Aurangabad

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We have been hired by a highly reputed and fast growing Pharma company to hire a "DGM - Formulation & Development' to be based at their plant located at Aurangabad . Details of the position are mentioned below: Role & responsibilities: Literature search/study and to prepare development trials strategies. Pre formulation study execution. Market/Innovator/reference product characterization. Execution and documentation of trial batches for prototype formulation development. Execution and monitoring of development stability studies. Execution of process optimization/scale-up batches. Technology transfer activities at site. Preparation/review of documents like BOM, MFR, compatibility study protocol & report, stability study protocol and report, PDR, etc as per requirements. Co-ordination with production, other relevant cross-functional departments/teams. Having experience/exposure of formulation development of solid oral, liquid, dry syrup, etc dosage forms aimed for ROW and domestic market. Should possess experience in handling various equipment like RMG, FBD/FBP, compression machine, roller compactor, coating machine, etc. Preferred candidate profile : Educational Qualification: M. Pharm Experience: 12 - 20 Years of relevant experience in a leading Pharma Company. Good Communication & Presentation skills Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak Director, Pharma Placements Inc. Mobile number: 98202 34987

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3 - 5 years

7 - 11 Lacs

Pune

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Job ID/Reference Code INFSYS-NAUKRI-210549 Work Experience 3-5 Job Title Payments - GPP Responsibilities Global Pay Plus - Payments Technical and Professional Requirements: PaymentsISO-20022 standards SWIFT, SEPA, MT messages Preferred Skills: Banking->GPP Financial Services Domain->Payments->GPP Generic Skills: Banking Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering * Location of posting is subject to business requirements

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2 - 5 years

5 - 7 Lacs

Navi Mumbai

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Role & responsibilities To review and understand technology of product from R&D scientist and coordinate, plan activities with all concerns personnel/ dept. for successful transfer of the products, Monitor tech transfer at site and update documents. To review and understand technology of product from CRO and coordinate, plan activities with all concerns personnel/ dept. for successful transfer of the products, monitor tech transfer at site and update documents. To resolve manufacturing issues/trouble shooting batches at manufacturing sites for the products which are commercialized. Monitoring of redeveloped formulations for quality improvement at manufacturing site. To develop new products as per requirement from business development team which involves pre-formulation studies, competitor product evaluation, prototype formulation development and stability batches manufacturing, stability charging and monitoring, preparation of R & D dossier etc with satisfactory stability studies. To work on quality improvisation and redevelopment projects at R & D To revise technical documents like MFR, FP Specifications after validation batches for changes, if any. To check/verify the documents like Process Validation Protocol and Process Validation Summary Report, APQR. To maintain and follow organizations rules and regulation. Preferred candidate profile 2 - 5 Years of experience in R & D. Qualification: M. Pharm | B. Pharm Specific Skills: Experience of technology transfer from R & D to manufacturing site, should have work on multiple projects in parallel. Should have experience of new product development for solid, semisolid and liquid dosage forms. Perks and benefits Company bus service.

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7 - 12 years

5 - 15 Lacs

Bengaluru, Hyderabad, Mumbai (All Areas)

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Role & Responsibilities: Head of Procurement for Finished Formulations Role: We are seeking an experienced leader for our procurement department specializing in finished formulations. This role demands expertise in the pharmaceutical industry, particularly in purchasing finished formulation products, and the ability to manage relationships with manufacturers and CDMOs effectively. Responsibilities: - Oversee and manage the procurement process for finished formulations, ensuring timely and cost-effective acquisition. - Build and maintain strong relationships with Contract Development and Manufacturing Organizations (CDMOs) involved in finished formulations. - Ensure thorough understanding and application of Certificates of Analysis (COA) to verify product quality and compliance. - Generate and manage purchase orders accurately, adhering to company policies and standards - Lead the procurement team, providing guidance and support to ensure departmental goals are met. - Address and resolve procurement challenges, including supply chain issues and vendor-related problems. - Negotiate favorable terms and rates with vendors and CDMOs to optimize cost and value. - Monitor market trends and industry developments to inform strategic procurement decisions. - Ensure all procurement activities adhere to regulatory standards and company policies. - Prepare and present detailed procurement reports to senior management, highlighting key metrics and performance indicators. - Work closely with other departments to align procurement strategies with overall business objectives. - Develop and implement strategies for procurement that support long-term business goals and operational efficiency. Requirements: - Proven experience in procurement of finished formulations within the pharmaceutical industry. - Strong relationships with API manufacturers and CDMOs. - Expertise in managing COAs and generating purchase orders. - Demonstrated leadership abilities and effective problem-solving skills. - Excellent negotiation skills and market insight. This role requires a seasoned professional with the ability to navigate complex procurement processes, maintain strong vendor and CDMO relationships, and lead a team effectively. Preferred Candidate Profile : - Over 5 years of experience in procurement for finished formulation products within the pharmaceutical industry. - In-depth knowledge of Certificates of Analysis (COA) and quality standards, with experience in generating and managing purchase orders for finished formulations. - Strong relationships with API manufacturers and Contract Development and Manufacturing Organizations (CDMOs) across India. - Comprehensive understanding of pharmaceutical finished formulations and industry trends. - Up-to-date with current market conditions and pricing for finished formulations. - Strong personality with excellent communication and email writing skills. - Proficient in price negotiation and convincing suppliers and CDMOs. - Capable of handling procurement challenges effectively, demonstrating responsibility and a pragmatic approach. - Ability to manage multiple procurement tasks efficiently and maintain detailed records. - Familiarity with regulatory requirements and adherence to company policies related to finished formulations. - Flexibility to adapt to changing market conditions and procurement needs. Perks and Benefits: - Positive work culture with a supportive and collaborative environment focused on professional growth. - Supportive colleagues and leadership committed to helping you succeed. - Access to timely assistance for any questions or issues. - Genuine and flexible leave policies to accommodate your personal needs. - Attractive incentive programs and performance-based bonuses. - Pathways for advancement, including in-house promotions and performance-based salary increases, without time constraints. - Opportunities to participate in team-building activities and outings. - Comprehensive health insurance coverage for you and your family, up to 15 lakhs. - Complimentary transportation services for convenience in your daily commute.

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4 - 8 years

3 - 8 Lacs

Palghar

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We are hiring for the following 2 positions: Senior Executive- Quality Control RM Section Head- 5-8 Years of Experience Executive- Quality Control- Analytical Method Validation- 4-6 Years of Experience 1. Senior Executive- Quality Control- RM (Raw Material) Section Head Raw Material Testing and Release: Supervise and ensure the testing of raw materials (active pharmaceutical ingredients, excipients, packaging materials) according to approved specifications. Lead the RM team in the timely testing and release of raw materials for production use, ensuring no delays in manufacturing. Ensure that the testing of raw materials is compliant with GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and other relevant regulatory standards. Supervision and Team Management: Lead, guide, and mentor a team of QC analysts in the RM section, ensuring effective training and development. Allocate tasks and manage workload distribution within the team to ensure smooth and efficient operations. Conduct regular performance appraisals, set objectives, and ensure team productivity and morale. Raw Material Specifications and Documentation: Review and ensure the accuracy and completeness of raw material specifications, test protocols, and related documents. Approve the testing methods and ensure compliance with the established standard operating procedures (SOPs). Ensure the proper maintenance of records related to raw materials, including stability studies, inventory control, and release certificates. Compliance and Regulatory Adherence: Ensure all raw materials and testing activities comply with the Indian Pharmacopeia (IP), USP, BP, and other regulatory standards. Ensure that all QC raw material processes are aligned with FDA, EMA, and other regulatory guidelines as applicable. Assist in audits (internal and external), and provide necessary data and reports during regulatory inspections. Equipment and Instrument Management: Oversee the calibration, maintenance, and qualification of equipment used in the RM section, ensuring accurate and reliable results. Ensure that the laboratory instruments and equipment are well-maintained and functioning optimally. Quality Control & Troubleshooting: Address any deviations, out-of-specification (OOS) results, or out-of-trend (OOT) findings related to raw material testing. Investigate and resolve any quality control issues, and recommend corrective and preventive actions (CAPAs). Lead root cause analysis and support the investigation of quality incidents related to raw materials. Vendor Management & Raw Material Supplier Interaction: Liaise with suppliers and vendors to ensure the timely and quality supply of raw materials. Participate in the selection and qualification of raw material suppliers and ensure they meet quality standards. Continuous Improvement and Efficiency: Identify opportunities for process optimization and recommend improvements to enhance operational efficiency. Ensure that the QC RM section continuously adheres to cost-effective practices, reducing wastage and improving turnaround time. Training and Knowledge Sharing: Train QC team members on analytical techniques, equipment usage, and quality control standards for raw material testing. Keep the team updated on industry trends, new regulatory guidelines, and best practices. Executive-Quality Control- Analytical Method Validation (AMV) Analytical Method Validation (AMV) : Conduct validation of analytical methods as per ICH, FDA, and other regulatory guidelines. Perform method development, optimization, and validation for raw materials, in-process materials, and finished products. Ensure adherence to validation protocols and documentation. Testing & Documentation : Oversee the execution of analytical testing for stability, release, and in-process samples. Review and verify analytical data, ensuring accuracy and completeness. Prepare and review validation reports, SOPs, and other related documentation. Compliance & Quality Assurance : Ensure compliance with GMP, GLP, ISO, and other relevant standards in laboratory activities. Support the QC team in audits (internal and external) and address any non-conformities. Ensure proper handling, storage, and disposal of chemicals, reagents, and samples in compliance with safety protocols. Equipment Maintenance : Coordinate with the maintenance team for the calibration and qualification of laboratory instruments. Perform routine checks and calibration of instruments used in testing and validation. Continuous Improvement : Actively participate in continuous improvement initiatives and training programs. Suggest and implement improvements in analytical methods and processes to enhance efficiency. Cross-Department Collaboration : Liaise with R&D, production, and regulatory teams to resolve technical issues. Assist in troubleshooting analytical issues in collaboration with the technical team

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3 - 8 years

6 - 12 Lacs

Hyderabad

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Role : Research Associate/ Sr. Research Associate - CMC (Analytical) Reports to : Associate Director - CMC (Analytical) Location : Hyderabad, India Qualification : M. Pharma/M.Sc. in Pharmaceutical Analysis/ Pharmaceutical Chemistry from reputed University. Experience : Around 3 to 8 years of experience in analytical method development, method validation for formulations. Purpose of the Role : Work both as an individual contributor and in collaboration with team to facilitate & drive timely achievement of CMC & R&D objectives, from CMC (Analytical) function. Job Description : Carry out Analytical method development and pre-validation involved in assigned projects, protocols & reports, in compliance with Ferring QMS to achieve the objectives as per project requirements. Author and review Analytical documents, not limited to method development reports, justification reports etc., to be built on strong scientific rationale, study designs & compliance with ICH, compendial & regulatory guidelines. Carry out & ensure Analytical deliverables for formulation development, optimization & scale-up, as applicable to achieve the objectives as per project requirements. Support Analytical method validation and method transfer involved in assigned projects to achieve the objectives as per project requirements. Preparation and updating of Specifications, STPs, analytical protocols and reports for assigned projects to achieve the objectives as per project requirements. Managing stability study related activities for assigned projects to achieve the objectives as per project requirements. Ensure external analysis co-ordination for routine & characterization tests and report review for assigned projects to achieve the objectives as per project requirements. Carry out literature search for analytical & regulatory aspects of assigned project to achieve the objectives as per project requirements. Review of ELN experiments, Data, Reports and documents generated within lab & those received from CRO/CMO in line with defined quality standards. Support procurement activities related to project & laboratory i.e. vendor contact, URS, SOW etc. in line with defined quality standards. Coordinating with Facility/Vendor for instruments and equipment AM, PM and regular maintenance in Analytical lab in line with defined quality standard. Preferred Competencies in the role. Working experience with diverse dosage form and differentiated products preferred. Timely achievement of the project deliverables GDP/GLP compliance ensured for data, lab operations & processes. Sound scientific & communication skills Strong Leadership Skills Critical thinking, troubleshooting and problem-solving skills. Engagement & accountability towards the defined purpose Good team player

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3 - 8 years

3 - 7 Lacs

Hyderabad

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Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

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3 - 8 years

3 - 8 Lacs

Gandhinagar, Ahmedabad

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Role & responsibilities Analytical Development Laboratory (ADL) Position: Executive Experience: 03-08 Years Qualification: M.Pharm / M.Sc Job/ Skill Set HPLC/GC/IC method development, feasibility, verification, equivalency, validation for complex OSD products, oncology products, topical products having exposure to regulated, Semi Regulated & India markets Comparative evaluation of methods with alternative vendor methods versus existing primary vendor and regulatory impact analysis Dissolution development, comparative dissolution, multimedia dissolution and statistical evaluation and report preparation Good understanding and hands on experience of analytical instruments like HPLC,IC, GC etc. NI/GI & NDSRI with LCMS/GCMS expertise, Solid state characterization and API sameness study Hands on experience on in-vitro Studies, E&L, Solid State characterization, IVPT/IVRT, Impurity characterization, sameness study Welversed with USP/EP/BP/IP and various current regulatory guidelines (ICH/EMEAVFDA) Perform maintenance and calibration of lab instruments / equipment Contact Details: Email : nitinsingh@torrentpharma.com

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2 - 7 years

2 - 6 Lacs

Baddi

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Designing and developing new pharmaceutical formulations based on project objectives. Modifying existing formulations to improve performance or address specific needs.

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8 - 12 years

12 - 15 Lacs

Baddi

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Regulatory Functional: Compilation of dossier for ROW market as per the country specific requirements (from Module-1 to Module 5) Ensure compliance to county specific regulatory requirements (i.e., Africa, ASEAN, CIA, Gulf, Asia pacific, Latin America) ¢ Ensure labeling compilation as per the country specific requirements ¢ Review of DMFs of complex peptide drug substances ¢ Post approval activity, variation filing (Major and Minor) as per change proposal recommend by the manufacturing site or client ¢ Experienced with handling drug device combination regulations and understand the requirements for submission in line country specific requirement (Prefilled syringes and disposable pens) ¢ To assure consistency and adequacy of submissions in line with current regulatory requirements/expectations ¢ Ensure timely response to the deficiencies received from the agencies ¢ To communicate & coordinate with different stakeholders within the organization/ third party contract manufacturers to resolve any delay in submissions ¢ Life cycle management of products to include renewals, reviewing & approving the change controls and ensures product continuity through filing and timely approvals of variations. Support the continuing activities through coordination with various stakeholder ¢ Approval package compilation and provides support for lunching of the approved product

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10 - 18 years

10 - 20 Lacs

Gandhidham, Kandla

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Key Responsibilities: Lead and oversee multiple R&D projects, focusing on the development of innovative pharmaceutical formulations, including long-lasting injections and oral dosage forms. Closely interact and work with various cross functional teams like procurement, QC, QA, finance, manufacturing, regulatory affairs, to ensure that project is executed on time. Identify & co-ordinate with suppliers of raw materials, packaging materials, equipment, etc. and external agencies for analysis, preclinical & clinical studies to ensure that project is executed on time. To arrange scale up trials of various dosage forms developed. Preparation of high quality technical documents. To mentor and develop junior scientists and researchers, fostering their growth and enhancing their technical expertise. Foster a culture of innovation and continuous improvement within the R&D team. To collaborate with external partners, CROs, and academic institutions to enhance R&D capabilities and accelerate product development. To represent the Company in scientific conferences, industry forums, and customer meetings, showcasing R&D achievements and capabilities. To provide technical support to business development teams in identifying and evaluating new business opportunities. Candidate profile: Ph.D. / M Pharm in Pharmaceutics with 10+years of experience in formulation R&D.

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4 - 9 years

4 - 9 Lacs

Navi Mumbai

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Positions 1) Technology Transfer Scientist (FRD) / 2- 6 years of experience 2) Documentation Lead (FRD)/ 3- 8 years of experience 3) Formulation Development Scientist/ 2- 10 years of experience 4) FRD Injectables / 2- 8 years of experience

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3 - 5 years

2 - 5 Lacs

Hyderabad

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Experience in pharmaceutical research, experimentation, and data interpretation based on the analytical results . Proficiency in laboratory techniques, handling of equipment’s and GMP knowledge. Good knowledge on the scale-up factors from R D to EB scale. Good formulation development knowledge and passion to become scientist. Knowledge on the pharmacokinetics of drugs is mandatory and proficiency in BE studies is required. Knowledge of regulatory requirements and quality standards in the pharmaceutical industry. Excellent problem-solving, critical thinking, and communication skills

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4 - 9 years

1 - 6 Lacs

Gurgaon

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Job Summary: Walter Bushnell is seeking a Research Associate Formulation with experience in Solid Oral Products to join our R&D team . The candidate will be responsible for formulation development, process optimization, and ensuring regulatory compliance for solid dosage forms. Key Responsibilities: Develop and optimize formulations for solid oral dosage forms (tablets, capsules, granules, etc.). Conduct pre-formulation studies, excipient compatibility tests, and stability studies . Perform process development, scale-up, and technology transfer for new formulations. Prepare and maintain technical documentation, protocols, and reports as per regulatory guidelines. Ensure compliance with cGMP, ICH, and regulatory standards for formulation development. Collaborate with analytical, regulatory, and manufacturing teams for successful product development. Troubleshoot formulation and process-related challenges to improve product stability and quality. Qualifications & Skills: Education: M. Pharm / B. Pharm in Pharmaceutics or related field. Experience: 4-5 years in formulation development of solid oral products . Strong knowledge of cGMP, ICH guidelines, and regulatory requirements . Hands-on experience in process optimization, scale-up, and tech transfer . Proficiency in documentation and regulatory compliance . How to Apply: Interested candidates can share their resumes at akanksha.jaiswal@walterbushnell.com . For further details, you can directly reach out at 7042636289 .

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15 - 18 years

20 - 25 Lacs

Paonta Sahib

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Job Role : Sr.Manager Production (OSD) Job Location : Poanta Sahib Job Function : Formulations (OSD) Education : Graduate in Pharmacy (B. Pharm) Experience : 15 to 18 yrs Job Summary 1. Manufacturing and Packaging operations of Oral Solid Formulation. 2. Documentation operations of General Solid Oral Manufacturing and Packaging Department. 3. Ensure that Investigations, CAPA, Batch Records preparation completion schedule is prepared, tracked and, execution of schedule as per plan. 4. Review and production approval of documents like: I. Commercial product, stability batches, exhibit batches, characterization Batches - Master Batch manufacturing record and Master Batch Packaging record. II. Risk assessment, process validation protocol, Incident and Investigation report, CAPA Reports. III. Protocols & reports. V. Internal Quality Audit, Regulatory Quality Audit Compliance. VI. Change control, Standard Operating Procedure, and other documents including amendments. 5. Provide leadership and expertise to ensure achievement of production with respect to Quality outputs and commercial demands. 6. To ensuring that there are appropriate manufacturing and technical processes and procedures in place for the production. 7. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. The production records are evaluated and signed by a designated person. 8. In coordination with Quality head monitor the factor that may affect product Quality compliance of GMP, retention of records. 9. To approve the instructions relating to production operations, including the in-process controls, and to ensure their strict implementation. 10. To check the maintenance of the department, premises and equipment. To ensure that the appropriate process validations and calibrations of control 1. equipment are performed and recorded and the reports made available. 2. To ensure that the required initial and continuing training of production personnel for SOP, cGMP, personal hygiene are carried out and adapted according to need. 3. Optimization of the resources like men, materials and machines in manufacturing and packing area. 4. Ensure efficient collaboration and co-ordination between relevant departments like Warehouse, Engineering, PPIC, Quality Control, Quality Assurance, procurement and management. Supporting Compliance of internal quality/corporate quality/regulatory audit. Planning & execution of various activities viz. Gap Analysis, enhancement, SOPs, protocols and reports etc. To perform Risk Assessment with respect to investigations, internal / regulatory observation response, market complaints and for system improvements etc. 8. To co-ordinate with FDD, PDD (R & D) /MSTG for execution of trial/exhibit /Process validation batches and trouble shooting. 9. Procurement of New Suitable Equipment's required for process as per cGMP requirements. 10. Identify and implement improvements to the production process, yield. 11. To ensure protection of the product from contamination. And monitor quality standards of products. 12. Shall delegate authority to deputed deputies with satisfactory level of qualification and experience. 13. Coach and develop direct and indirect reporters through on going, example based performance feedback, annual performance reviews and provision of training and development opportunities. 14. Assure all time readiness department for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies and internal audit teams. 15. Shall participate in Internal Quality Audit. 16. Responsible for ensuring market complaints, failures deviations are investigated and corrective and preventive actions are implemented as per set timeline. 17. Performs all work in support of our Corporate Values of pride- Humility, Integrity, passion and with accountability and diligence. Perform all work in accordance with all established regulatory and compliance and EHS requirements. Reporting Manager Comments

Posted 2 months ago

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2 - 7 years

2 - 7 Lacs

Ahmedabad

Work from Office

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Unison Pharmaceuticals is urgently seeking talented Production Supervisors for our OSD Production team. Apply now to become a part of our team!! Experience: 2-6 years Job Role : 1) Compression Supervisor 2) Granulation Supervisor Designation: Officer / Sr. Officer / Executive Qualification: B.Pharma/M.sc Location: Moraiya, Ahmedabad. No. of Openings : 3 Perks & Benefits Dynamic work environment Career development opportunities Work-life balance Free transportation 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 industry and possess the required skills, we encourage you to apply for this position. Please submit your resume to career@unisonpharmaceuticals.com to be considered for this role. Join our team at Unison Pharmaceuticals and take the first step towards a rewarding career. Regards HR department

Posted 3 months ago

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