Gmp Auditor-pharma

3 months ago

Viman Nagar Pune Maharashtra, India Pharma Jobs India Full time

**GMP Auditor (Pharmaceutical Quality)**

**LEAD AUDITOR-GMP** (for **Pharmaceutical Formulations** Exporting European Company)
- **(Only those who are GMP Quality Auditors with pharmaceutical formulations companies need apply).**_

Someone who has experience in a multinational company and has been exposed to UK/EU and FDA audits at least as an auditee. We might find people who specialize in Laboratory/Analytical (than Production) would be more suitable. Also experience with Sterile and Non-Sterile would be relevant.
- Managing the audit program
- Leading audits (GMP, qualification of new suppliers, for-cause etc)
- Ensuring that high quality, relevant, reports and generated in a timely manner and closely followed up with the site to ensure CAPAs implemented
- Leading the engagement of third party auditors in remote geographies if needed e.g. Canada etc
- Managing and mentoring direct report(s) in Pune and guiding audit activities needed in Australia & other countries if other staff here participate e.g warehouses

The Lead Auditor will work collaboratively with the Operations team, Scientific Affairs team and stakeholders to define and deliver quality and compliance plans and objectives. This is to ensure the products supplied to our customers meet the relevant regulatory standards, contractual obligations, and our internal quality standards.

The Lead Auditor manages and delivers Company's Supplier Audit program to ensure Company's quality and compliance standards are communicated and maintained. Responsibililties include managing the audit program and auditing staff; performing routine GMP, for-cause and due-diligence audits of current and potential suppliers/manufacturers; delivering audit reports; ensuring CAPAs are addressed and closed in a timely manner; and maintaining the audit system and metrics.

The Lead Auditor will ensure that all activities are completed with the highest level of care and accuracy, and in a timely manner to maintain continuity of supply. In addition, the role will focus on continuously improving our compliance stature by ensuring our suppliers meet regulatory requirements and Company's quality expectations.

**ACCOUNTABILITIES AND RESPONSIBILITIES**

**Accountability Area % of Role**

**Key Activities and Responsibilities**

Supplier Audit and Qualification Program

65%
- Manage the Supplier Audit program including audit scheduling, reporting, follow up on CAPAs and generation of associated metrics
- Collaborate with internal stakeholders to understand the business needs and context driving the Audit and Qualification program
- Schedule and perform supplier audits as Lead Auditor
- Perform GMP audits to assess and assure existing supplier compliance profiles.
- Perform due diligence audits to assess the quality and compliance risk profile for new suppliers and contract manufacturers.
- Perform for-cause audits to investigate and assess the risk posed by suppliers that have reported significant, repetitive deviations or quality issues, or suppliers that have had adverse regulatory authority findings made against them.
- Deliver reports of appropriate accuracy, detail and quality dependent on type and findings of audit, Reports should be precise, concise, and delivered in a timely manner.
- Ensure appropriate assessment of issues, and timely execution, closure and effectiveness of CAPAs in response to supplier audit findings such that suppliers maintain compliance to Company's quality standards.
- Develops and directs Auditors including direct report(s), staff supporting audits from other Company's offices
- Advises on and leads the engagement of third party auditors when required to cover remote geographies.

Quality management system, governance and metrics

20%
- Develop policies, procedures, systems and metrics in relation to supplier audits.
- Maintain and continuously improve processes and procedures to ensure efficient and compliant ways of working.

Quality Risk Management

10%
- Collaborate with stakeholders to prioritise audit schedule and audit focus based on
- business context such as volume, significance to the portfolio
- supplier and product quality and compliance history such
- Assign and maintain supplier risk ratings matrix

Health, Safety and Wellbeing / General

5%
- Adhere to the Company's Health, Safety and Wellbeing policy, procedures and systems.
- Maintain a clean and orderly workplace.
- Take reasonable care for own and others health and safety.
- Participate in health and safety training.
- Identify hazards and incidents in the workplace and if not immediately controllable, report and inform hazards and incidents in accordance with policy to relevant persons and management.
- Champion Company's Mission, Aims, Objectives and Values.
- Work cooperatively with colleagues across the Company.
- Actively participate in opportunities to communicate within Company's including attending team meetings.
- Demonstrate a willingness to work flexibly with others to

  • Expert Gmp Auditor

    3 months ago

    Mumbai, Maharashtra, India Novartis Full time

    **Summary**: Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external targets...

  • Food Safety Auditor

    3 months ago

    Andheri, Mumbai, Maharashtra, India Aluco Glazing Full time

    **Key Responsibilities**: - Act as an auditor in multiple standard (i.e. FSSC 2200, ISO 22000, Quality management system standard. - Key account management, scheduling of audit programmes as per agreed timelines, review and vetting of audit reports, service delivery as per agreed SLA. - Design, implement and deliver FSMS programme along with GMP and HACCP...

  • Purchase Executive

    1 month ago

    Pune, Maharashtra, India Nissar Transformers Pvt Ltd Full time

    Position: Purchase Executive(Pharma/ food/ nutra) Position category: Senior team member Unit / Department: Materials Minimum Qualification: Graduate or Post Graduate with first class in Science/ Commerce Total years of Experience: 8 - 10 years in sourcing and procurement of raw material/ assets development of vendors, budgeting shall be given...

  • Purchase Executive

    2 weeks ago

    pune, India Vitasta Consulting Pvt Ltd Full time

     Minimum Qualification : Graduate or Post Graduate with first class in Science/ Commerce  Total years of Experience : 8 - 10 years in sourcing and procurement of raw material/ assets Preference : Candidates having experience in GMP rules of pharma and nutra.  Mandatory Qualities : Identification and development of vendors, should have skill...

  • Purchase Executive

    5 days ago

    Pune, India Vitasta Consulting Pvt Ltd Full time

    Minimum Qualification: Graduate or Post Graduate with first class in Science/ Commerce Total years of Experience: 8 10 years in sourcing and procurement of raw material/ assets Preference: Candidates having experience in GMP rules of pharma and nutra. Mandatory Qualities: Identification and development of vendors should have skill set to develop...

  • Executive- Ncq

    4 months ago

    Mumbai, Maharashtra, India Novartis Full time

    394397BR **Executive - NCQ**: India **About the role** Executive-NCQ Location - Mumbai #LI Hybrid About the Role: Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems Key Responsibilities: - Support management of document based GMP...

  • Career Opportunity in Retail Marketing

    3 months ago

    Charkop, Mumbai, Maharashtra, India Rusan Pharma Full time

    Greetings, Let me take this opportunity to introduce our company to you. Rusan is a fully integrated global pharmaceutical Company specialized in the treatment of addiction (drugs, alcohol, smoking) and Pain Management. It is indeed true that the performance of any company is a reflection of the people working within the company. Rusan Management...

  • Gvp Auditor

    3 months ago

    Mumbai, Maharashtra, India Adamas Consulting Full time

    **Company Description** ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems...

  • Purchase Executive

    5 days ago

    pune, India Vitasta Consulting Pvt Ltd Full time

     Minimum Qualification: Graduate or Post Graduate with first class in Science/ Commerce  Total years of Experience: 8 - 10 years in sourcing and procurement of raw material/ assets Preference: Candidates having experience in GMP rules of pharma and nutra.  Mandatory Qualities: Identification and development of vendors, should have skill set to develop...

  • Executive-complaint Hub

    3 months ago

    Mumbai, Maharashtra, India Novartis Full time

    **Summary**: - Responsible for the managing day to day process of Complaint management activities under NCQ complaint hub responsibility. Identification, reporting and escalation of critical complaint events followed by building the strong collaboration with NCQ sites to ensure customer service, compliance, and efficiencies. -Manages Quality aspects and...

  • Pharma Purchase Executive

    3 weeks ago

    Andheri, Mumbai, Maharashtra, India Acugen lifesciences Pvt Ltd Full time

    **Job Title**: Pharma Purchase Executive **Location**: Mumbai Andheri **Department**: Procurement/Supply Chain **Reports to**: Purchase Manager/Procurement Head **Key Responsibilities**: - **Procurement Planning**: - Understand and analyze requirements for pharmaceutical products, raw materials, and equipment. - Develop procurement strategies based on...

  • Officer Technology Scale Up

    2 weeks ago

    Navi Mumbai, Maharashtra, India Shri Management Services Full time

    Navi Mumbai, Turbhe Midc - Facebook - Instagram - WhatsApp - Twitter - Linkedin - Pinterest Person having Diploma in Chemical Engineering or B.Sc. in Chemistry with hands on knowledge and experience of Instrumentation & Control including DCS based systems. Relevant experience of operating Active Pharmaceutical Ingredient (API) plants under GMP for more than...

  • Field Sales Representative

    1 month ago

    Punawale, Pune, Maharashtra, India Nsk Engineers Full time

    **Job Title: Field Sales Executive** **Industry: Industrial Sales (Pharma, Beverage, Chemical)** **Job Summary**: **Responsibilities**: - Identify and pursue new sales opportunities with pharma, beverage, and chemical companies - Build and maintain strong relationships with key decision-makers and stakeholders - Conduct sales meetings, product...

  • Account Executive

    3 months ago

    Prahlad Nagar, Ahmedabad, Gujarat, India GMP Machineries & PAckaging Full time

    1 Sales Entry - Check Sale invoice - Export and GST Invoice with Shipping, Packing List, PFI, and Inventories - Prepare E Invoice & E-Way Bill 2 Purchase Entry - Check the Purchase invoice as per PO - Check the GST Credit as per Invoice - Deduction of TDS under 194Q if applicable - Check the all-related document like E-ways, Transport LR Copy etc.. 3...

  • Gcp Auditor

    1 month ago

    Mumbai, Maharashtra, India Adamas Consulting Full time

    **Company Description** ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems...

  • Purchase (Packaging Material)

    3 months ago

    Pune, India VEKO CARE PVT LTD Full time

    **Company Overview**: **VEKO CARE PVT LTD** Veko is a new entrant in the pharmaceutical field, having its factory approved for GMP from Australian FDA, WHO GMP, UGANDA, KENYA & ZAMBIA. Veko has state of art new factory for Pharmaceuticals with a specialization in Veterinary Medicine at Ranjangaon MIDC near Pune. The factory is designed & made as per the...

  • QA Executive

    4 months ago

    Bandra, Mumbai, Maharashtra, India AMN LIFE SCIENCE PVT LTD Full time

    Ensuring the System to be followed as per written procedure and SOP. - Ensure all activities to be done by quality parameters without deviating any SOP. - Online Documentation of all log books and respective Analytical documents - Review and Approval of artwork/ shade card Mangement of artwork/shadecard of all products as per regulated body like TGA, CDMO,...

  • Purchase Executive

    2 weeks ago

    Pune, India Vitasta Consulting Pvt Ltd Full time

    MinimumQualification:Graduate or Post Graduate with first class in Science/CommerceTotal years of Experience: 8 10 years insourcing and procurement of raw material/ assetsPreference: Candidates having experience in GMPrules of pharma andnutra.Mandatory Qualities: Identification anddevelopment of vendors should have skill set to develop vendors asper GMP...

  • Pharma Quality Assurance(Male Only)

    3 months ago

    Rajendra Nagar, Indore, Madhya Pradesh, India Instrumentation & Control Solution- ICS Full time

    Hiring Hiring Hiring !!!!!!! Position Title : Quality Assurance (Male) No of vacancies: 01 Location : Indore (Rajendra Nagar) Experience : Minimum 1 to 2 years experience in QA Responsibility - 1-A quality assurance trainer maintains quality training requirements in compliance with FDA and other regulations. 2-Maintaining up-to-date training records and...

  • Regulatory Affairs Associate

    3 months ago

    Mumbai, Maharashtra, India Planet Science Full time

    **About Us**: An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO** **Position - Regulatory Affairs Associate.** An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having...