Sr.Manager / DGM - Sterility Assurance

2 days ago

New Delhi, India SUN PHARMA Full time

Job Role : Sr.Manager / DGM - Sterility Assurance Location : Halol - VadodaraJob Summary: In this Job role we are looking for Sterility Assurance, QMS elements for Sterile manufacturing Units with experience in Regulatory Audit Queries.Responsibilities :Owning of Aseptic process simulation program of the site including protocol / operators and intervention qualification program / Trending and Aseptic process simulation summary report. Own and continually develop the Site’s Contamination Control Strategy. Ensure Contamination control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Lead Sterility Assurance committee for the site . Review and approval of Microbiological environmental monitoring program, identify trends and implement effective risk mitigation Guide the investigation of contamination – related non-conformance and events and provide technical input for microbiological method transfers. Serve as subject matter expert on sterility assurance during regulatory inspections, audits and cross functional initiatives. Support inspection preparation and execution during health authority on-site inspection as an expert in Sterility Assurance Assess differences in current sterility assurance programs across the sites and drive harmonization Provide mentoring leadership to site SMEs to help build continue to build capability on Sterility assurance program, where deep technical expertise is lacking Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the network. Maintain compliance with governing regulations and lead by example in promoting best contamination control practices through ongoing training and floor presence Collaborate with operations and QC micro lab to design and deliver robust training programs on aseptic processing, aseptic behavior and principles for site staff. acting as the site's subject matter expert during audits Identify opportunities for process improvement in aseptic techniques. The lead mentors and develops junior sterility assurance staff and site SMEs to build technical expertise within the organization Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.Education : M.SC / B.Pharm / M.Pharma Experience : 15+ Years (with Sterile / Regulatory Plants)

  • Manager / Sr.Manager - Global Quality Sustainability, Training and Quality Culture

    2 weeks ago

    Delhi, India SUN PHARMA Full time

    Role : Manager / Sr.Manager - Global Quality Sustainability, Training and Quality CultureLocation : VadodaraResponsibilities :Setting up baseline data for sustainability projects and Quality Cultural from various SUN sites.Assessment, interpretation and review of baseline data and support site representatives in data assessmentsParticipate and drive assigned...

  • AGM/ DGM

    2 weeks ago

    Delhi, Delhi, India Sant Nirankari Health City Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    JOB TITLE: AGM/DGM-OPERATIONSLocation: Sant Nirankari Health City, DelhiOverview: AGM/ DGM Operations is responsible for overseeing and managing the day-to-day administrative and operational functions of the hospital to ensure high-quality patient care, operational efficiency, and compliance with healthcare regulations. The role demands strong leadership,...

  • Deputy General Manager Operations

    2 days ago

    New Delhi, India Valkyrie People Consulting Full time

    Job Title: Deputy General Manager (DGM) - OperationsLocation: Mumbai, MaharashtraIndustry: AutomotivePosition Overview:We are looking for an experienced Deputy General Manager (DGM) of Operations to lead and optimize our operational processes within the automotive sector. The ideal candidate will bring strong expertise in operational management, production...

  • Quality Assurance Engineer

    3 weeks ago

    Delhi, India Madhu Instruments Pvt Ltd Full time

    Urgent Job opening for Quality Assurance Executive Responsibilities · To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 9001 & 13485, 93/42/EEC Directive including- · Technical files making & updating including risk management, clinical evaluation, post market surveillance, quality plan, ESRs, etc....

  • Quality Assurance Engineer

    1 week ago

    Delhi, Delhi, India Madhu Instruments Pvt Ltd Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    Urgent Job opening for Quality Assurance ExecutiveResponsibilities· To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 9001& 13485, 93/42/EEC Directive including-· Technical files making & updating including risk management, clinical evaluation, post market surveillance,quality plan, ESRs, etc.·...

  • Quality Assurance Executive

    1 week ago

    Okhla, Delhi, Delhi, India Madhu Instruments Full time

    To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 9001 & 13485, 93/42/EEC Directive including - Technical files making & updating including risk management, clinical evaluation, post market surveillance, quality plan, ESRs, etc. - Fulfilment of regulatory requirements related to EC directive, various...

  • Qc Microbiologist

    3 days ago

    Okhla Industrial Area Phase-i, Delhi, Delhi, India Devine Meditech Full time

    **Job Title**: QC Microbiologist - Medical Devices **Department**: Quality Control (QC) **Reports To**: QC Manager / Quality Head **Job Type**: Full-time **Job Summary**: We are seeking a **QC Microbiologist** to ensure the highest microbiological quality standards in our **medical devices manufacturing** process. The role involves conducting...

  • Operation Theatre Technician

    7 days ago

    Delhi, Delhi, India RG Stone Urology & Laparoscopy Hospital Full time

    Designation: Operation Theatre Technician (Male) - Gagan Vihar (Preet Vihar) Qualification: Diploma/Bachelor in OT Department: Operation Theatre Work Experience: 2+ Years Total Opening: 1 Location: Gagan Vihar, New Delhi **Job Description**: **POSITION GUIDELINES** **DOCUMENT- JOB DESCRIPTION/ RESPONSIBILITIES** **DEPARTMENT : OPERATION...

  • Quality Control – Microbiologist

    2 weeks ago

    Delhi, India AQF Ingredients Full time

    Job Title: Quality Control – Microbiologist (Entry-Level) Department: Quality Control / Quality Assurance Location: Ahmedabad Job Type: Full-Time | Entry-Level Job Summary: We are seeking a detail-oriented and motivated Entry-Level Microbiologist to join our Quality Control team. The ideal candidate will be responsible for conducting microbiological...

  • Operation Theatre Technician

    7 days ago

    Delhi, India RG Stone Urology & Laparoscopy Hospital Full time

    Job Description Job Description POSITION GUIDELINES Document- Job Description/ Responsibilities DEPARTMENT : OPERATION THEATRE POSITION : TECHNICIAN -SCRUB REPORTING TO : IN CHARGE - OPERATION THEATRE QUALIFICATION : DIPLOMA IN OPERATION THEATRE EXPERIENCE : 1 YEAR OR MORE Note- We are looking OT Technician having good exposure of assisting surgery...