Executive, MS

4 weeks ago

Bengaluru, India Apotex Full time

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: .

Job Summary

Site technology Transfer: Internal product technology transfers from an Apotex manufacturing site to Apotex research private limited (ARPL), India.Transfer of products from Small Volume Manufacturing Plant to Large Volume Manufacturing Plant and Vice versa within ARPL. Technology transfer of New products: New product transfer from formulation development to commercial scale. Manufacturing process support: Technical support for the trouble shooting of processing issues in Commercial batch manufacturing. Product Life cycle Management (PLCM) : Technical support to ensure robustness of product/process through out its life cycle. Supplier driven changes (SDC) : Change or addition of a source or supplier driven change in raw material (API & Excipients) manufacturing process for existing commercial products. Documentation: Documentation support for the MTS activities. All other relevant duties as assigned.

Job Responsibilities

Site technology Transfer: Review of Technical data package and tooling drawings and Provide support for manufacturing license application.Preparation of technical documents with respect to site transfer such as Form-C,MFR,Technology Transfer Protocol and Report,TRE, Protocols and reports for PO,PD,PPQ,CPV and Hold Study batches,Placebo Formulation sheets,TRA.Monitoring of PO/PD/PPQ batches.Ensure archival of PO/Placebo batch documents to QA and any other activities as assigned. Technology transfer of New products: Preparation of the technical documents with respect to Technology transfer of new products such as Form-C,MFR,TRE,Protocols and reports for PO,PD,PPQ,CPV and Hold Study batches,Placebo Formulation sheets,TRA.Monitoring of PO/PD/PPQ batches and any other activities as assigned. Manufacturing process support: Troubleshooting of processing issues for commercial batch manufacturing at shop floor.Manufacturng process support in the event of any issues which are unplanned and require immediate resolution.Preparation of TSR, TIR or Subject Matter Expert (SME) Response for an investigation according to QMS Track Wise Investigation procedures. Product Life cycle Management (PLCM): Preparation of the technical documents with respect to PLCM products such as Technical summary report (TSR),Technical Investigation Report (TIR), TRE, Protocols & Reports for PO,PD,Process verification,PPQ and CPV batches,TRA.Monitoring of PO/PD/PPQ batches. Supplier Driven changes (SDC): Preparation of the technical documents with respect to SDC products such as MAR,MFR,TRE,Protocol & Report forPO,PD,Process verification,PPQ & CPV batches,TRA, Placebo formulation sheet. Monitoring of PO/PD/PPQ/Procss Verification batches. Documentation: Preparation of the following documentation requirements for the MTS activities such as Product code Allocation, MFR,Technology transfer Protocol and Report for Manufacturing & Packaging, TRE, Protocol & reports for PO, PD,PPQ, CPV and hold time study batches,Technical Investigation report,SME analysis report,Technical Summary report,MAR, Placebo Formula sheet, Technical Summary report, Master Manufacturing Record (MMaR) Assessment, Other documentation activities Eg: but not limited to Justification report,Manufacturing Process comparison,Training documentation,Pre-requisite checklists (Part A & Part B),Revision of Standard Operating procedure, Formats.Ensure work is performed in full compliance with good manufacturing practices, standard operating procedures, established safety standards, and regulatory requirements. Coordinate with various departments such as Mfg, Pkg, FD, WH, QA Validation related to document review and approvals,technical processing issues and equipment failures.To perform all work in accordance with all established regulatory and compliance and safety requirements.

Job Requirements

Education Master Degree in Pharmacy or Science. Experience: 2 year-4 years Knowledge, Skills and Abilities: Should have knowledge of process development and Technology transfer on Solid dosage forms for regulated markets like USA, Europe, Canada and Australia is essential.Should have a good understanding of Product development process along with scale-up knowledge of the product and Process Validation.Should have good understanding of clinical and regulatory requirements of USA, Canada, Australia, and European regulatory agencies.Should have good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet.Possesses/develops the ability to adapt to frequent changes in priorities and schedules.The willingness to upgrade knowledge/education on an on-going basis.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

  • Executive Assistant to Chief Executive Officer

    7 days ago

    Bengaluru, India Achyutam-Executive Search Services Full time

    **Roles and Responsibilities** To manage Director’s competing demands with a high degree of confidence and professionalism and to make a significant contribution to the effective performance of Director. Excellent communication & open to travel. Hands on experience on MS Excel. **Perks and Benefits** Role: - Other- Salary: - Not Disclosed by...

  • Ms Team Administrator

    6 days ago

    Bengaluru, India CIEL HR Services Full time

    Roles & Responsibilities of MS Teams Administrator (L3): - L3 should have overall 8+ years of experience & 4+ years of experience in Microsoft Teams, OneDrive, SharePoint administration - Troubleshoot audio and video quality issues. - Investigate issues with call quality and dropped calls by using Call Quality Dashboard, network tracing tools, and logs....

  • Accounts Executive

    4 weeks ago

    Bengaluru, Karnataka, India NIBS Full time

    Accounts Executive MS excel expert Good English communication Ready to work in Electronic City location 3-4 years of Experience in Accounts and Excel domain JD Assets Managements. **Job Types**: Full-time, Permanent Pay: ₹30,000.00 - ₹34,900.00 per month **Benefits**: - Health insurance - Provident Fund Schedule: - Day shift Supplemental pay...

  • Business Development Manager-Genomics

    4 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Business Development - GenomicsCompany: MS Clinical Research Pvt Ltd-BangaloreLocation: BangaloreAbout Us:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to leveraging cutting-edge technologies and innovative methodologies to...

  • Business Development Manager-Genomics

    4 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Business Development - GenomicsCompany: MS Clinical Research Pvt Ltd-BangaloreLocation: BangaloreAbout Us:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to leveraging cutting-edge technologies and innovative methodologies to...

  • Business Development Manager-Genomics

    4 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Business Development - Genomics Company: MS Clinical Research Pvt Ltd-Bangalore Location: Bangalore About Us: MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to leveraging cutting-edge technologies and innovative...

  • Executive - Customer Service

    6 days ago

    Bengaluru, India Ms. Prerana Motors Pvt Ltd Full time

    Executive - Customer Service Reputed Automobile Dealership for TATA Motors Ltd., looking for talented youngsters to join their Motor Insurance team at Central Bangalore. You will be responsible for timely issuance of motor policies to new customers by co-ordinating with the sales team, answering customer queries and working on dedicated software. Entry...

  • MS-SQL Administrator

    3 weeks ago

    Bengaluru, India Kyndryl Full time

    Who We AreAt Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities.The RoleRoles &...

  • Clinical Research Associate

    3 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Clinical Research Associate (CRA)Company: MS Clinical Research Pvt LtdAbout Us:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative medical...

  • Clinical Research Associate

    3 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Clinical Research Associate (CRA)Company: MS Clinical Research Pvt LtdAbout Us:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative medical...

  • Clinical Research Associate

    3 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title : Clinical Research Associate (CRA) Company : MS Clinical Research Pvt Ltd About Us : MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative...

  • MS-SQL Administrator

    4 weeks ago

    Bengaluru, India Kyndryl Full time

    Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The...

  • Se - Ms-SQL L2

    4 weeks ago

    Bengaluru, India CGI Full time

    **Company Profile**: **Job Title**: MS SQL L2 **Position**: System Engineer **Experience**: 4 - 6 Years **Category**: Software Development/ Engineering **Main location**: India, Karnataka, Bangalore **Position ID**: J0523-1324 **Employment Type**: Full Time **Qualification**: Bachelor's degree in Computer Science or related field or higher with...

  • Executive IT Support

    6 days ago

    Bengaluru, India Ms. Prerana Motors Pvt Ltd Full time

    **Role: Asst. Manager IT / Sr. Executive IT/Executive IT** **Experience**:Min**. 2** to 5 years’ Experience in IT industry (systems & networking) **Qualification**:Diploma (CS), B.Sc. (CS), BCA, other graduates can also be considered depending upon Knowledge & Experience. **In-Charge of**:CVD SALES -Lalbagh Road (all branches including 1S). **1.**...

  • Specialist System Engineer-MS Exchange

    5 days ago

    Bengaluru, India HTD Resources Full time

    Specialist System Engineer-MS Exchange - (240007K1) Missions Level Matrix- MS ExchangeCategory- L2, Exp: 4-6 yrsBudget: 8.5 LPAServices-IMSWork under pressure and fast-paced environment to resolve issues quickly and ensure the daily operation is smooth. 1) Very good understanding of Microsoft Exchange and Mobility topics.2) Sound knowledge of Exchange and AD...

  • Specialist System Engineer-MS Exchange

    5 days ago

    Bengaluru, India HTD Resources Full time

    Specialist System Engineer-MS Exchange - (240007K1) Missions Level Matrix- MS ExchangeCategory- L2, Exp: 4-6 yrsBudget: 8.5 LPAServices-IMSWork under pressure and fast-paced environment to resolve issues quickly and ensure the daily operation is smooth. 1) Very good understanding of Microsoft Exchange and Mobility topics.2) Sound knowledge of Exchange and AD...

  • Executive Taxation

    6 days ago

    Bengaluru, India Ms. Prerana Motors Pvt Ltd Full time

    Executive Taxation & Internal Audit 1. Good Knowledge of GST, TDS, TCS 2. GST, TDS, TCS Filing & returns Knowledge 3 Good Accounts with SAP Knowledge 4. Good Communication 5. Good Statutory Compliance Knowledge etc **Salary**: ₹20,000.00 - ₹26,000.00 per month **Benefits**: - Health insurance - Leave encashment - Provident Fund Schedule: - Day...

  • Executive Customer Experience

    5 days ago

    Bengaluru, India Ms. Prerana Motors Pvt Ltd Full time

    CUSTOMER EXPERIENCE EXECUTIVE. 1. Attending the customer calls 2.Co-ordinate with Sales & Back End Team. 3. Updating to customer time to time. 4. Confirm the payment & Vehicle Delivery Process. 5. Arranging the Vehicle delivery Celebration. 6. Tracking 7. Post Delivery Calls to Customers 8. Any other work entrusted by superior time to...

  • ERP Manager

    2 weeks ago

    Bengaluru, India HeadPro Consulting LLP Full time

    Job Title : Deputy Manager / Manager - ERP & Software Development Responsibilities- As a D365 F&O Developer, you will be responsible for designing and developing customized solutions within the D365, Axapta and Power Platforms- This includes coding, unit testing, building applications, creating, building integrations, and troubleshooting existing...

  • MS Technical Specialist

    4 weeks ago

    Bengaluru, India Global Pharma Tek Full time

    Primary Skill Set – Palo Alto & Checkpoint Location – Bangalore Experience – + years Relevant experience – + years Shifts – / Notice Period - Immediate to days Technical Mandatory + years of experience in Cisco, Juniper, Check Point and Palo Alto Firewall products Knowledge of Firewall (Cisco, Checkpoint, Palo Alto, Juniper) and VPN...