Quality Assurance Executive Qms

2 weeks ago


Ahmedabad Gujarat, India Nexus pharmachem Pvt Ltd Full time

Job Responsibility

Knowledge Required

OOS, OOT

Deviation

Incident

Change Control

Process Validation

Cleaning Validation

Site master file

Drug Master File
- Responsible for the quality assurance of the batches manufactured
- Responsible for identifying the training requirements of the manufacturing and maintenance personnel and
- imparting the required training.
- Responsible for technical review during new supplier registration and coordinating the inspection of purchased
- Responsible for Calibration/Validation activity.
- Responsible for guiding the Q.C. personnel in attending to Q.C. related problem
- Responsible for batch release.
- Authorized for carrying out corrective and preventive actions.
- Experience in developing, reviewing and approving cGMP and ISO related documents (SOPs, protocols, reports, etc)
- To complete the sample request from different customer which include sample preparation, documentation, COA preparation, packing and dispatch of free sample to the customer and maintain all the required and supporting document.
- To cater and address different Vendor Qualification Documentation requirement like VQ questionnaire, quality agreements, declaration of regulatory compliance documents against the request came from different customer.
- Provide technical support to cleaning activities associated with the manufacturing process.
- Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under development cleaning procedures.
- Supports the periodic review of cleaning validation studies.
- Issues Change Controls required for the implementation of cleaning procedure changes, as needed.
- Checking the quality of incoming and returned materials and component as per specification.
- Review and update standard operating procedures (SOPs) to align with changing regulations and best practices. Documentation And Records Management
- Maintain and manage documentation related to quality assurance activities, including batch records, investigation reports, change controls, and validation documentation.
- Ensure accurate and timely completion of all quality-related documentation. Product Quality Control
- Investigate product non-conformances, deviations, and customer complaints to identify root causes and implement appropriate corrective and preventive actions (CAPAs).
- Knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards.
- Making decisions on batch disposition and product recall based on root cause identification.
- Reviewing and approving compliance reports following external (customer/regulatory) audits and corporate audits to ensure compliance.
- Preparing and implementing quality assurance policies and procedures and ensure that standards and safety regulations are observed.
- Timely completion of APQR related activity
- Prepared & Review of Validation protocol and report (like Process Validation, Cleaning Validation, Analytical Method Validation,)
- Handling of Market Complaint and Related Compliance
- Handling of out of specification and suitable investigation
- Handling of Deviation and Incident
- Prepared BMR, SOP, Protocols etc.
- Compliance of Vendor Audit, Regulatory Audit etc.

Role: QA Executive

Industry Type: PharmaceuticalAPI

Department: Quality Assurance

Employment Type: Full Time, Permanent

Role Category: Quality Assurance

**Education**

UG: B.Sc / B. Pharm

PG: M.Sc / M. Pharm

Knowledge of computer competence, including database management

Minimum Experience Required: 1 - 4 Year

CV Required

Contact:
Contact: 9909906884

**Job Types**: Full-time, Permanent

**Salary**: ₹15,000.00 - ₹30,000.00 per month

**Benefits**:

- Leave encashment

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

**Education**:

- Bachelor's (preferred)

**Experience**:

- Maximum: 1 year (preferred)

**Speak with the employer**
+91 9909906884


  • Qms

    3 days ago


    Sanand, Ahmedabad, Gujarat, India Samarthhrconsultant Full time

    Quality Assurance (QMS) BSc / MSc / B.Pharm/M.Pharm Officer / Executive 2-4 Year QMS Activities such as Change Control, Deviation, CAPA, Investigation, Market Compliant, Faced Audit, Audit Reports Preparation. Sanand Ahemdavad Pay: From ₹12,000.00 per month **Experience**: - total work: 1 year (preferred) Work Location: In person Application...


  • Ahmedabad, India Talencia Integrated Solutions Full time

    Position: Quality Assurance Executive Responsibility: - Knowledge of **ISO 9001:2015 (QMS)**: - experience in root cause analysis, CAPA, and 8D - Knowledge of **repairing electronics** items preferably **Mobile and Set Top Box**. Qualification Preferred: Graduate/Post Graduate in Electronics / Mechanical Engineering Experience: 2-5 Years **Salary**: Up...


  • Rakhial, Ahmedabad, Gujarat, India QARMATEK SERVICE PVT LTD Full time

    Job Description:Basic knowledge of soldering and electronics components.Knowledge of electronics repair (Mobile, Set Top Box) Particular Job Title Executive Quality Assurance Job Description 1.Should be very good in communication and team-leading with a positive approach 2.Should have experience in electronics repair like mobile phones, set-top box, etc....


  • Surat, Gujarat, India QMS India Full time

    Job Title: - QA -Executive Location: - Palsana Surat Business: - Manufacturing of Masterbatch & compounds Qualification: - BSc. / Diploma in Plastic Experience: - 3 to 4 yrs (Must have knowledge of Polymer Granule Masterbatch Manufacturing Industries) **Computer skills**: SAP & MS Office Salary 3 to 6 lpa **Role & Responsibilities** - Proven...


  • Surat, Gujarat, India QMS India Full time

    Job Title: - QA -Executive Location: - Palsana Surat Business: - Manufacturing of Masterbatch & compounds Qualification: - BSc. / Diploma in Plastic Experience: - 3 to 4 yrs (Must have knowledge of Polymer Granule Masterbatch Manufacturing Industries) **Computer skills**: SAP & MS Office Salary 3 to 6 lpa **Role & Responsibilities** - Proven...


  • Sanand, Ahmedabad, Gujarat, India Samarthhrconsultant Full time

    Quality Assurance (QMS) BSc / MSc / B.Pharm/M.Pharm Officer / Executive 2-4 Year Sanand Ahemdavad Pay: From ₹12,000.00 per month **Education**: - Bachelor's (preferred) **Experience**: - total work: 1 year (preferred) Work Location: In person **Speak with the employer** +91 6359421763 Application Deadline: 10/06/2024 Expected Start Date:...


  • Vadodara, Gujarat, India Rishika Health Full time

    Hiring quality assurance executives urgently for api and intermediate manufacturing at Nandesari Gujarat. Preparation and review of documents like specification, STP, stability protocol, stability data. Preparation and review of documents like QMS like change control, deviation, complaint, BMR review, PVR & CVR, Internal audit, training etc., Dispatch...


  • Ahmedabad, Gujarat, India Nexus pharmachem Pvt Ltd Full time

    Job Responsibility Knowledge Required OOS, OOT Deviation Incident Change Control Process Validation Cleaning Validation Site master file Drug Master File - Responsible for the quality assurance of the batches manufactured - Responsible for identifying the training requirements of the manufacturing and maintenance personnel and - imparting the...


  • Ahmedabad, Gujarat, India Nexus pharmachem Pvt Ltd Full time

    Job Responsibility Knowledge Required OOS, OOT Deviation Incident Change Control Process Validation Cleaning Validation Site master file Drug Master File - Responsible for the quality assurance of the batches manufactured - Responsible for identifying the training requirements of the manufacturing and maintenance personnel and - imparting the...

  • Analytical Research

    2 weeks ago


    Ahmedabad, Gujarat, India Zydus Group Full time

    Department - ZRC QUALITY - Job posted on - Feb 22, 2024 - Employment type - P-P6-Probationer-R&D Executive - **Job Responsibility** - Reporting to In-charge Quality Assurance of Analytical department.- Planning, Conducting, and Reporting of system audits.Responsible for archival/retrieval of QA documents. Coordinating and conducting trainings. Review,...


  • Ahmedabad, India HomeNurse4U Private Limited Full time

    To assist the QA Management, to maintain an effective Quality Management System (QMS). Ensure compliance with ICH guidelines and regulatory requirements and provide support to the HomeNurse4U (HN4U) functions with regards to Quality Assurance (QA). - Assists in maintaining QMS - Supports in hosting sponsor audits and regulatory inspections - Tracks and...


  • Ahmedabad, Gujarat, India HomeNurse4U Private Limited Full time

    To assist the QA Management, to maintain an effective Quality Management System (QMS). Ensure compliance with ICH guidelines and regulatory requirements and provide support to the HomeNurse4U (HN4U) functions with regards to Quality Assurance (QA). Assists in maintaining QMS Supports in hosting sponsor audits and regulatory inspections Tracks and assists in...

  • Quality Assurance

    3 days ago


    Vadodara, Gujarat, India Larsen & Toubro Full time

    Quality Assurance & Control LNT/QA-C/944559 - L&T Energy - HydrocarbonKnowledge City Vadodara - Posted On 05 Feb 2024- Required Experience 4 - 8 Years**Skills**: Knowledge & Posting Location QUALITY ASSURANCE QUALITY MANAGEMENT Minimum Qualification B.TECH/B.E **Job Description**: - Scope Of Work* - Primary - Responsible for institutionalizing...

  • Sr Assoc, Quality

    4 weeks ago


    Ahmedabad, India Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Sr Assoc, Quality

    4 weeks ago


    ahmedabad, India Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found...


  • Ahmedabad, Gujarat, India QARMATEK SERVICE PVT LTD Full time

    1.Should be very good in communication and team-leading with a positive approach 2.Should have experience in electronics repair like mobile phones, set-top box, etc. 3.Should have experience in in-process, final inspection and pre-delivery inspection, etc. in quality department 4.Should have knowledge of ISO 9001:2015 (QMS) & expertise in preparing...

  • Quality Controller

    2 months ago


    Ahmedabad, Gujarat, India SUNTARA COSMETICS Full time

    **Overall management of QA, QC Responsibilities for ancillary materials** - **Overall management of ancillary materials (Printing/Lacquering/Foiling/Metallizing/Assembling/Moulding)** **Overall management of QA, QC Responsibilities for ancillary materials produced from injection molding, lacquering, foiling, screen printing, metallizing & assembling**. To...

  • Quality Assurance

    2 weeks ago


    Ahmedabad, India Zymo Cosmetics Full time

    **Job Function**: Quality Assurance The Quality Assurance Specialist will be responsible for ensuring that all skincare products manufactured by the company meet regulatory, safety, and quality standards. They will work closely with the manufacturing, research and development, and quality control teams to ensure that products are manufactured according to...


  • Jarod, Vadodara, Gujarat, India JVS INDUSTRIES PVT LTD Full time

    QA Engineer with 3 to 5 years of working experience in the API oil field equipment manufacturing facility. Must be be B.tech/Diploma in mechanical engineering. He shall hold a qualified internal auditor certification per ISO 9001 and API Q1. Can independently establish, implement and maintain the quality management system as per API spec Q1. Work with QA...


  • Sanand, Ahmedabad, Gujarat, India Hindustan Coco-Cola Beverages Full time

    Job Description- To ensure all the products manufactured and distributed by the bottling operation conform to the specifications through assurance of processes from supply to consumer. The QAE supports the identification, planning, documentation, and management of the practices, activities and resources needed to meet quality goals and objectives in a manner...