Global Quality Lead

6 days ago

Dadra, India SUN PHARMA Full time

Job Title: Sr. Manager – Global Quality Lead Business Unit: Global Quality & Compliance Job Grade G9B Location : Mumbai At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Position Summary : Manage overall batch certification review of QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, instrument preventive maintenance/calibration/qualification/validation as per good manufacturing practices/good documentation requirements and ALCOA++ principles). This role will be an individual contributor with expert in manufacturing investigations from FDA approved facilities that make sterile and OSD products.  The incumbent will assure individual compliance with all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures. Key Responsibilities : Lead the review of all QC records related to Batch certification program. QA SME for manufacturing & packaging Investigations (Sterile & OSD) Batch Certification activities at Dadra and possibly other sites in India. Experience in manufacturing contract manufacturing organizations, inculding Batch records, investigations and product quality compliants. Experience in FDA and Health Canada inspections Review Deviations, CAPAs, OOS/OOT investigations. Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc. Review initiated CAPA records related to QC investigations for completeness and adequacy. Review and approval of qualification, analytical method transfer, validation protocol and reports for accuracy, completeness and traceability as well as adherence to the Protocol/procedures. Training of QC and QA teams. Work in partnership with Quality Control and Quality Assurance. Follow the EHS policy, laboratory procedures and maintain the compliance to cGMP requirements. Travel Estimate Job Requirements Educational Qualification B.Pharm / M.Pharm Experience Tenure: 15 to 17 Yrs Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

  • Quality Analyst Lead

    2 weeks ago

    Dadra and Nagar Haveli, India Sterlite Technologies (STL) Full time ₹ 15,00,000 - ₹ 30,00,000 per year

    Role & responsibilitiesMaintain strong technical knowledge of Optical Connectivity Solutions, including components, assembly processes, and product performance parameters, to ensure quality standards are met and to support product and process improvement initiatives.Stay abreast of market trends, emerging technologies, and quality management best...

  • Quality Assistant

    6 hours ago

    Dadra, India LINEAR DESIGN Full time

    **Job Purpose**:Quality assistants are responsible for ensuring that products in production meet the safety and specification standards necessary for them to be forwarded to the last production stage. **Role**: Quality Assistants complete duties assigned by quality managers, such as handling customer complaints, training new staff, implementing quality...

  • Quality Control Engineer

    2 weeks ago

    Dadra and Nagar Haveli, India UDYOGI Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Company DescriptionUdyogi is a leading safety solutions provider offering a wide range of integrated safety products, services, and training that adhere to global safety standards. With over 40 years of expertise, Udyogi specializes in risk assessment and the development of high-quality safety solutions to ensure workforce safety, comfort, and productivity....

  • Quality Assurance Sublead

    4 days ago

    Dadra and Nagar Haveli, India Sterlite Technologies Ltd Full time ₹ 2,00,000 - ₹ 4,00,000 per year

    1 OpeningDadraRole descriptionRole Purpose: Key Accountabilities: Preferred Experience and Qualification:About STL and STL DigitalAbout STL - STL is a leading global optical and digital solutions company providing advanced offerings to build 5G, Rural, FTTx, Enterprise and Data Centre networks. About STL Digital - STL Digital, a wholly owned subsidiary of...

  • Officer/ Executive

    4 days ago

    Dadra, India Ami Polymer Pvt. Ltd Full time

    1)Preparation of Quality Manual as per updated ISO 13485:2016 and ISO 9001:2015 2) Review and update change controls related to NPD Projects (New Product Development) and other required change 3) Preparation of Dossiers for Semi-Regulated market and Non-Regulated market according to CTD format and ACTD. 4) Prepare Site master file and device master file as...

  • Ah Die Shop Operation

    1 week ago

    Dadra, India Aditya Birla Group Full time

    **Designation**:Assistant Manager **Updated**:October 15, 2024 **Location**:Dadra and Nagar Haveli, India **Organization**:Metals **Job Purpose**: - Plan, monitor, and control the operation of Manufacturing activities to ensure the availability of high-quality extrusion dies. - Ensure die manufacturing activities within budgeted costs and in a safe...

  • Dh Die Manufacturing

    2 days ago

    Dadra, India Aditya Birla Group Full time

    **Designation**:Assistant General Manager **Updated**:January 15, 2025 **Location**:Dadra and Nagar Haveli, India **Organization**:Metals **Job Purpose**: - Plan, monitor, and control the operation of Manufacturing activities to ensure the availability of high-quality extrusion dies. Presses from all extrusion plants in India for day-to-day production...

  • Senior Officer

    6 days ago

    Dadra, India SUN PHARMA Full time

    Job Title: Senior Officer / Executive – MSTG Orals Business Unit: R&D1 Regulatory Affairs Job Grade G12B/G12A Location Dadra At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own...

  • Dh Die Design

    2 days ago

    Dadra, India Aditya Birla Group Full time

    **Designation**:Assistant General Manager **Updated**:January 15, 2025 **Location**:Dadra and Nagar Haveli, India **Organization**:Metals **Job Purpose** - Plan, monitor, and control the operation of Die Design and Simulation activities to ensure the availability of high-quality validated die designs for manufacturing. - Development of 3D models of the...

  • Ah Liaison

    6 hours ago

    Dadra, India Aditya Birla Group Full time

    **Designation**:Manager **Updated**:August 30, 2024 **Location**:Dadra and Nagar Haveli, India **Organization**:Metals **Job Purpose**: To serve as a pivotal link between our organization and external stakeholders, working closely with the Unit HR Head to facilitate a harmonious collaboration. Your role involves streamlining communications and...