Head - Quality & Regulatory - Diagnostic Manufacturing/IVD Industry

3 weeks ago


Mumbai, India P R GLOLINKS CONSULTING PRIVATE LIMITED Full time

What we are looking for

- Candidate should be around 15 years of experience in Manufacturing industry with USFDA/WHO approved Company in Quality Function.

- Experience in Diagnostic Manufacturing Company will be an added advantage.

- Expertise and Experience in handling multiple products and sites.

- Effective Man Management skills.

- In-depth knowledge of regulations of the concerned markets.

- Candidate should be good in handling documentation & all other Quality Compliances.

Key Responsibility Quality Management:

- Establish and maintain a robust quality management system (QMS) that complies with relevant standards and regulations (e.g., ISO 13485, FDA, WHO-PQ regulations).

- Implement effective quality control processes throughout the manufacturing cycle, including raw material inspection, production monitoring, and final product release.

- Define and track key quality metrics, such as product defect rates, customer complaints, and non-conformance incidents, to drive continuous improvement.

- Conduct regular internal audits and coordinate external audits by regulatory bodies or certification agencies.

Regulatory Compliance :

- Stay updated on the latest regulatory requirements and standards relevant to IVD testing kits in the countries/regions where your products are marketed.

- Ensure timely submission of regulatory filings and documentation for new product registrations, variations, and renewals, in collaboration with regulatory affairs teams.

- Establish processes for regulatory monitoring, tracking changes in regulations, and assessing the impact on product compliance.

- Work closely with cross-functional teams to ensure compliance with labeling requirements, post-market surveillance, adverse event reporting, and other regulatory obligations.

Product Development and Lifecycle Management:

- Collaborate with R&D and product development teams to ensure that quality and regulatory considerations are integrated into the design and development of new IVD testing kits.

- Conduct risk assessments and implement risk management strategies throughout the product lifecycle.

- Oversee the validation and verification processes for new products or changes to existing products, ensuring adherence to applicable standards.

- Develop and maintain technical documentation, such as product specifications, manufacturing instructions, and product change control records.

In addition he will be responsible for

- Supplier Quality Management

- Customer Satisfaction

- Continuous Improvement

(ref:iimjobs.com)

  • mumbai, India Michael Page Full time

    Opportunity to work with a leading European public health organization Best in-class industry experience and benefits About Our Client A United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for LMICs. Through its innovative business model, it partners with civil...


  • Mumbai, India archerchem healthcare pvt ltd Full time

    **ob description** **Urgently Required Regulatory Affair for Formulation** **Roles and Responsibilities** 2) To check artworks for regulated/ semi regulated countries. 3) To co-ordinate for documents and samples for regulatory submissions with manufacturing locations LL & 3rd party manufacturing 4) Handling of queries pertaining to regulatory...


  • mumbai, India Michael Page Full time

    Only candidates with 15 + years of experience should apply Only candidates from chemicals education background should apply About Our Client Our client is a global MNC in the specialty chemicals industry which manufactures soaps, surfactants, detergents and laundry chemicals. It has 65 manufacturing units worldwide and operates in 128 countries...


  • Mumbai, Maharashtra, India Glendale Biomed Pvt. Ltd Full time

    **Vacancy**: For Regulatory affairs officer **Job description** **Roles and Responsibilities** 2) To check artworks for regulated/ semi regulated countries. 3) To co-ordinate for documents and samples for regulatory submissions with manufacturing locations LL & TP 4) Handling of queries pertaining to regulatory submissions from various regulatory...


  • Mumbai, India haystack Analytics Full time

    Who areweBased out ofIIT Bombay HaystackAnalytics is a HealthTech company creatingclinical genomics products which enable diagnostic labs andhospitals to offer accurate and personalized diagnostics. Supportedby Indias most respected science agencies (DST BIRAC DBT) wecreated and launched a portfolio of products to offer genomics ininfectious diseases. Our...

  • Qc/qa Officer

    4 weeks ago


    Lower Parel, Mumbai, Maharashtra, India EDGEPHARMA Full time

    **Job Summary**: **Responsibilities**: - Develop and implement quality assurance processes and procedures to ensure that products meet regulatory requirements and quality standards. - Conduct internal audits of quality systems and processes, and develop corrective action plans to address any deficiencies. - Develop and implement training programs for...


  • Mumbai, India Apt Resources Full time

    **Certified Diagnostic Technician (CDT)**: - **Location: Warli mumbai** **Those who comfortable for this location, only apply** **Rounds-F2F** Duties & responsibilities: - Diagnose & rectify the various electrical related faults in different systems of cars by using the diagnostic tool and electrical wiring diagram. 1. Drive train (Engine, Transmission...


  • Navi Mumbai, India Aumnatic Systems Pvt Ltd Full time

    Company DescriptionAumnatic Systems Pvt Ltd is an Electronic System Design and Manufacturing (ESDM) Startup based in Navi Mumbai. They specialize in engineering design and quality manufacturing with a focus on sectors including Transport, Medical Devices, and Toys. Aumnatic has developed and deployed hardware devices used in transport ticketing, such as...


  • navi mumbai, India Aumnatic Systems Pvt Ltd Full time

    Company Description Aumnatic Systems Pvt Ltd is an Electronic System Design and Manufacturing (ESDM) Startup based in Navi Mumbai. They specialize in engineering design and quality manufacturing with a focus on sectors including Transport, Medical Devices, and Toys. Aumnatic has developed and deployed hardware devices used in transport ticketing, such as...


  • Navi Mumbai, India Aumnatic Systems Pvt Ltd Full time

    Company DescriptionAumnatic Systems Pvt Ltd is an Electronic System Design and Manufacturing (ESDM) Startup based in Navi Mumbai. They specialize in engineering design and quality manufacturing with a focus on sectors including Transport, Medical Devices, and Toys. Aumnatic has developed and deployed hardware devices used in transport ticketing, such as...


  • Mumbai, India Aum Global Solutions Full time

    **Position Overview**: **Responsibilities**: - Coordinate and oversee day-to-day manufacturing activities in the injectable formulation unit. - Ensure adherence to standard operating procedures (SOPs) and good manufacturing practices (GMP) throughout the manufacturing process. - Monitor production schedules and prioritize tasks to meet production targets...


  • Mumbai, India Shri Management Services Full time

    Mumbai, Worli Duties & responsibilities: - Diagnose & rectify the various electrical related faults in different systems of cars by using the diagnostic tool and electrical wiring diagram. 1.Drive train (Engine, Transmission etc.). 2.Comfort and safety system (climate control system, Restraint System, Onboard Electrical, Networking (CAN & LIN), Lighting...


  • Navi Mumbai, India Aumnatic Systems Pvt Ltd Full time

    Company DescriptionAumnatic Systems Pvt Ltd is an Electronic System Design and Manufacturing (ESDM) Startup based in Navi Mumbai. They specialize in engineering design and quality manufacturing with a focus on sectors including Transport, Medical Devices, and Toys. Aumnatic has developed and deployed hardware devices used in transport ticketing, such as...


  • navi mumbai, India Michael Page Full time

    Be a part of the leading specialty pharmaceutical CDMO for regulated markets Opportunity to work with one of the fastest growing organization in the industry About Our Client The organization is into specialty pharmaceutical formulations focused on complex generics for regulated markets. Job Description MAIN PURPOSE OF THE JOB : *To...


  • Mumbai, India Zieva Farm Pvt Lt Full time

    Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies - Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications, Product packaging, Artwork etc. - Provide expert regulatory input...

  • Plant Head

    1 week ago


    mumbai, India Industrial Rubber Products, L.L.C. Full time

    Role DescriptionThis is a full-time on-site role located in Mumbai for a Plant Head at Industrial rubber products Pvt ltd. The Plant Head will be responsible for overseeing the overall operations of the plant, including production, quality control, supply chain management, and maintenance. They will lead a team of employees, ensure that production targets...


  • Mumbai, India SUN PHARMA Full time

    JD for Global Head of Projects (Grade: Sr. GM) Job Purpose Global Head of Projects will oversee all engineering projects activities globally. The incumbent will be responsible for overseeing the planning , execution and completion of various engineering projects while ensure adherence to timelines, budgets and quality standards. Key...


  • mumbai, India SUN PHARMA Full time

    JD for Global Head of Projects (Grade: Sr. GM) Job Purpose Global Head of Projects will oversee all engineering projects activities globally. The incumbent will be responsible for overseeing the planning , execution and completion of various engineering projects while ensure adherence to timelines, budgets and quality standards. Key...


  • mumbai, India SUN PHARMA Full time

    Global Head of Engineering & Energy Consumption (Grade: AVP)Job PurposeGlobal Head of Engineering & Energy Consumption will oversee all engineering maintenance activities globally as well as lead our energy management efforts within the organization. The role is responsible for driving continuous improvement initiatives to enhance operational efficiency and...


  • Mumbai, India SUN PHARMA Full time

    DESIGNATION : Head – Microbiology DEPARTMENT & SUB AREA : Quality and Microbiology ACADEMIC QUALIFICATION : Minimum M.Sc. Microbiology TOTAL EXPERIENCE : Minimum 15 + Years RESPONSIBILITY : Job Summary : Responsible for Oversight and Monitoring of Microbiology Laboratory at the site. This position shall be responsible to assure...