Manager - QA/RA

1 week ago

Navi Mumbai, India Septodont Healthcare India Pvt Ltd Full time

Work Location: Taloja MIDC, Navi Mumbai, Maharashtra.


About Septodont:


At Septodont, we are spreading smiles worldwide. With over 90 years of excellence globally & 25 years domestically, we've been at the forefront of revolutionizing dental care worldwide. Our commitment to quality, innovation, and patient well-being drives us to continually push the boundaries of dental science. As a global leader in dental solutions, we're dedicated to empowering dental professionals and improving patient outcomes everywhere.


Septodont communicates a culture of growth and opportunity, enticing top talent to join its dynamic team. With a focus on nurturing talent, fostering creativity, and promoting diversity in the workplace, Septodont presents itself as a people-oriented employer that looks after the professional development of its team. Aspiring candidates are drawn to the company's reputation for fostering a collaborative environment where ideas flourish and individuals thrive.


If you're ready to embark on a rewarding journey with a global leader in dental innovation, we invite you to apply for the Manager - QA/RA position at Septodont India.


Work Location: Taloja MIDC, Navi-Mumbai, Maharashtra.


Job Summary: The Quality Assurance/Regulatory Affairs Manager is responsible for ensuring that the company’s products comply with all regulatory standards and that quality systems are maintained and improved. This role involves overseeing quality assurance processes, managing regulatory submissions, and ensuring compliance with applicable regulations and standards. The QA/RA Manager works closely with cross-functional teams, including product development, manufacturing, and marketing, to support the lifecycle of the company's products from development through commercialization.


Key Responsibilities:

  • Oversee Quality Management System (QMS), policies and standards to support proper and smooth execution of Quality related activities in meeting the specified standards and requirements, consistent with GMP.
  • Ensure risk management principles are implemented throughout the organization in all activities.
  • Establish a company quality plan including quality policy (based on corporate QA policies and procedures) and continually improve it. Promote quality achievement and performance improvement throughout the organization and report the performance of the QMS to upper management.
  • Ensure deviations/non-conforming product management and implement preventive measures and corrective actions. Evaluate and ensure CAPA effectiveness.
  • Ensure Quality Management System complies with per Drugs and Cosmetics Act, Medical Device Rule 2017, MDD & Medical Device Regulations and is effectively established, maintained and efficient
  • Ensure suppliers' and customers' qualifications, and maintain their approved status according to applicable procedures. Manage change controls and authorize their implementation after assessment and approval from authorities/notified body/legal manufacturer.
  • Oversee internal audits as well as vendor/supplier/customer audits as per GMP & ISO 13485 & ISO22716 & MDR requirements. Prepare and implement the project inspection strategy to cover all project phases from the QA/RA perspective.
  • Facilitate and manage inspection or audit from customer, notified body and regulatory authorities and their follow-up actions. Continuously review quality control processes, procedures, and capabilities to sustain the most cost-effective and efficient methods for meeting quality requirements and make recommendations for improvement as appropriate.
  • Manage and control all quality control activities in accordance with identified Quality Assurance standards, company procedures, client specifications and contract requirements.
  • Assist in the production of generic and project-specific method statements and risk assessments. Handle all product complaints and taking proper corrective measure under root cause analysis.
  • Provide training to all employees related to ISO, MDR, GMP and Medical device regulations as per EU. Ensure all regulatory compliances related to products and processes are met.
  • Ensure regulatory watch and quality standard watch applicable to QMS and QC test.
  • Ensure process validation, cleaning validation, equipment and utilities qualification and monitoring, revalidation program and calibration.
  • Ensure batch record review and approve batch disposition.
  • Handle in Process QA activities of manufacturing and packaging areas.
  • Conduct and document management review, follow and communicate KPIs as defined.
  • Approve and coordinate any returned products and disposal of returned products.
  • To follow and adhere the requirement as mention in the following standard ISO 13485, ISO 22716, cGMP, MDR-2017


Qualifications:

• Minimum bachelor’s degree in science or related field (Biomedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.), or experience demonstrating equivalent required knowledge and competencies.

• Certification in a regulatory or quality discipline would be an asset (IGMPI)

• 5+ years in a quality assurance management role in Medical Device and leadership equivalent role;

• Effective communication and report writing skills;

• Good negotiating skills with a customer-oriented attitude;

• Excellent analytical abilities to grasp the key points from complicated details;

• Good leadership qualities to lead projects to successful completion;

• Basic knowledge of applicable software to infer statistical data;

• Familiarity with the tools, concepts and methodologies of quality management;

• Knowledge of and experience with all regulatory requirements concerning class I, II and III devices including

• Knowledge of QSR/QMS to support ISO-13485, ISO22716, GMP, Medical Device Regulation (2017/745), compliance/processes, CE Marks and audits;

• Experience with lab work;

• Familiarity with manufacturing techniques, project management and formal continuous process improvement techniques (Lean Management).

  • Manager - QA/RA

    1 week ago

    Navi Mumbai, India Septodont Healthcare India Pvt Ltd Full time

    Work Location: Taloja MIDC, Navi Mumbai, Maharashtra.About Septodont:At Septodont, we are spreading smiles worldwide. With over 90 years of excellence globally & 25 years domestically, we've been at the forefront of revolutionizing dental care worldwide. Our commitment to quality, innovation, and patient well-being drives us to continually push the...

  • Manager - QA/RA

    1 week ago

    Navi Mumbai, Maharashtra, India Septodont Healthcare India Pvt Ltd Full time

    Work Location: Taloja MIDC, Navi Mumbai, Maharashtra.About Septodont:At Septodont, we are spreading smiles worldwide. With over 90 years of excellence globally & 25 years domestically, we've been at the forefront of revolutionizing dental care worldwide. Our commitment to quality, innovation, and patient well-being drives us to continually push the...

  • Manager - QA/RA

    5 days ago

    Navi Mumbai, India Septodont Healthcare India Pvt Ltd Full time

    Work Location: Taloja MIDC, Navi Mumbai, Maharashtra.About Septodont:At Septodont, we are spreading smiles worldwide. With over 90 years of excellence globally & 25 years domestically, we've been at the forefront of revolutionizing dental care worldwide. Our commitment to quality, innovation, and patient well-being drives us to continually push the...

  • Manager - QA/RA

    1 week ago

    navi mumbai, India Septodont Healthcare India Pvt Ltd Full time

    Work Location: Taloja MIDC, Navi Mumbai, Maharashtra. About Septodont: At Septodont, we are spreading smiles worldwide. With over 90 years of excellence globally & 25 years domestically, we've been at the forefront of revolutionizing dental care worldwide. Our commitment to quality, innovation, and patient well-being drives us to continually push the...

  • Manager - QA/RA (Urgent)

    2 days ago

    Navi Mumbai, India Septodont Healthcare India Pvt Ltd Full time

    Work Location: Taloja MIDC, Navi Mumbai, Maharashtra.About Septodont:At Septodont, we are spreading smiles worldwide. With over 90 years of excellence globally & 25 years domestically, we've been at the forefront of revolutionizing dental care worldwide. Our commitment to quality, innovation, and patient well-being drives us to continually push the...

  • Manager - QA/RA M/F

    1 week ago

    Navi Mumbai, India Septodont Full time

    Job SummaryWork Location: Taloja MIDC, Navi-Mumbai, Maharashtra.The Quality Assurance/Regulatory Affairs Manager is responsible for ensuring that the company’s products comply with all regulatory standards and that quality systems are maintained and improved. This role involves overseeing quality assurance processes, managing regulatory submissions, and...

  • Manager - QA/RA M/F

    1 week ago

    Navi Mumbai, Maharashtra, India Septodont Full time

    Job SummaryWork Location: Taloja MIDC, Navi-Mumbai, Maharashtra.The Quality Assurance/Regulatory Affairs Manager is responsible for ensuring that the company's products comply with all regulatory standards and that quality systems are maintained and improved. This role involves overseeing quality assurance processes, managing regulatory submissions, and...

  • Manager - QA/RA M/F

    2 weeks ago

    navi mumbai, India Septodont Full time

    Job Summary Work Location: Taloja MIDC, Navi-Mumbai, Maharashtra. The Quality Assurance/Regulatory Affairs Manager is responsible for ensuring that the company’s products comply with all regulatory standards and that quality systems are maintained and improved. This role involves overseeing quality assurance processes, managing regulatory...

  • Manager - QA/RA M/F

    2 weeks ago

    Navi Mumbai, India Septodont Full time

    Job Summary Work Location: Taloja MIDC, Navi-Mumbai, Maharashtra. The Quality Assurance/Regulatory Affairs Manager is responsible for ensuring that the company’s products comply with all regulatory standards and that quality systems are maintained and improved. This role involves overseeing quality assurance processes, managing regulatory...

  • Ra / QA - Executive (Api - Pharmaceuticals

    2 weeks ago

    Mumbai, India Modern group PVT LTD Full time

    **Job description** - To prepare documents for local regulatory submission. - To review batch manufacturing records protocols and reports of all Active Pharmaceuticals Ingredients and Intermediates to support DMF / FILING. - To prepare Standard Operating Procedures for all departments. To perform product quality review. Follow quality assurance systems as...

  • QA Officer

    7 days ago

    Mumbai, Maharashtra, India SSterling Workforce Enterprises Private Limited Full time

    **Key Responsibilities** QA - Maintaining Production and Factory records as per ISO 13485 RA-Preparation and maintaining records of the document as per MDR-2017 and ISo 13485 **Qualifications** Bachelor's degree in Science Experience - 1 - 3 years Pay: ₹20,000.00 - ₹25,000.00 per month Schedule: - Day shift Work Location: In person

  • Marketing Executive in Pharmaceutical API Industry

    4 hours ago

    Navi Mumbai, India Seven Consultancy Full time

    JOB DETAILS1) Support Manager Business Development in API Marketing efforts with Indian domestic market & Regulated market customers in India.2) Should be able to handle communication independently with customers & satisfy their requirements by co-ordinating with Plant , QA and R&D.3) Good Communication skills, both verbal & written Previous experience in...

  • Team Member

    2 days ago

    Vikhroli, Mumbai, Maharashtra, India Cipla Full time

    **Division**: - IPD**Department**: - IPD**Employment Type**: - Permanent**Job Purpose**: Submit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products...

  • Risk Advisory RA

    1 month ago

    mumbai, India KPMG India Full time

    About KPMG in India KPMG entities in India are professional services firm(s). These Indian member firms are affiliated with KPMG International Limited. KPMG was established in India in August 1993. Our professionals leverage the global network of firms, and are conversant with local laws, regulations, markets and competition. KPMG has offices across India in...

  • Risk Advisory RA

    2 weeks ago

    mumbai, India KPMG India Full time

    About KPMG in India KPMG entities in India are professional services firm(s). These Indian member firms are affiliated with KPMG International Limited. KPMG was established in India in August 1993. Our professionals leverage the global network of firms, and are conversant with local laws, regulations, markets and competition. KPMG has offices across India in...

  • Marketing Executive in Pharmaceutical API Industry

    1 week ago

    Navi Mumbai, Maharashtra, India Seven Consultancy Full time

    JOB DETAILS 1) Support Manager Business Development in API Marketing efforts with Indian domestic market & Regulated market customers in India.2) Should be able to handle communication independently with customers & satisfy their requirements by co-ordinating with Plant , QA and R&D.3) Good Communication skills, both verbal & written Previous experience...

  • Executive- QA

    3 weeks ago

    Mumbai, Maharashtra, India High Career Full time

    Roles & Reasponsiblities: This role will be responsible for - Handling vendor approval requests - filling forms, Questionnaires, sharing FAQ, documents etc. - Handling regulatory requests / queries from customers. - Sending notification to customers, answering queries, and maintaining data base - Comparing COA, Specification, test methods and providing...

  • Risk Advisory RA

    1 month ago

    Mumbai, India KPMG India Full time

    About KPMG in India KPMG entities in India are professional services firm(s). These Indian member firms are affiliated with KPMG International Limited. KPMG was established in India in August 1993. Our professionals leverage the global network of firms, and are conversant with local laws, regulations, markets and competition. KPMG has offices across India in...

  • Marketing Executive in Pharmaceutical API Industry

    1 month ago

    navi mumbai, India Seven Consultancy Full time

    JOB DETAILS 1) Support Manager Business Development in API Marketing efforts with Indian domestic market & Regulated market customers in India.2) Should be able to handle communication independently with customers & satisfy their requirements by co-ordinating with Plant , QA and R&D.3) Good Communication skills, both verbal & written Previous...

  • Marketing Executive in Pharmaceutical API Industry

    3 weeks ago

    navi mumbai, India Seven Consultancy Full time

    JOB DETAILS 1) Support Manager Business Development in API Marketing efforts with Indian domestic market & Regulated market customers in India.2) Should be able to handle communication independently with customers & satisfy their requirements by co-ordinating with Plant , QA and R&D.3) Good Communication skills, both verbal & written Previous...