Executive - Quality Assurance
Thermo Fisher Scientific
Haiderabad, UP, India
13d ago
source : CareerArc Group LLC

Job Description

Job Title : Executive - Quality Assurance

Job Location : Hyderabad

When you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you.

Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

About Team : Laboratory Solutions India (LSI) unites deep scientific expertise, a collaborative culture and rich resources to deliver lab chemicals, equipment and consumables that our customers need to achieve their scientific goals quickly, reliably and safely.

  • Laboratory Chemicals provides over 100,000 catalog products ranging from solvents, reagents, catalysts, organic building blocks, screening libraries, analytical standards, bioreagents, precious metals, salts and solutions
  • Laboratory Equipment category includes equipment, accessories, and services for sample preparation, storage and protection, and analysis.
  • Laboratory Consumables category includes sample preparation and storage, liquid handling, and specialty plastics and services.
  • Our smart lab solutions make it faster and easier for our customers to focus on what matters most delivering answers and innovations that save and improve lives.

    Purpose of role :

    Lead the Quality and Operations for Production Chemicals (Pharmacopeia Grade Chemicals) and provide Technical and Regulatory support to drive the Business

    Key Responsibilities :

  • Implementation and monitoring of Quality Systems at manufacturing plant.
  • Preparation and Revision of all documents of QA, QC, Production and Operation.
  • Maintenance of current and obsolete documents so that documents can be retrieved fast.
  • New Vendor development and conduct audits as per the audit plan.
  • Conduct audits of the manufacturing locations as per plan.
  • Regulatory support for compliance and documentation for manufacturing plant.
  • Dealing with Regulatory authorities which include preparation of documents like application, response on regulatory observation and visiting authorities as and when required.
  • Handling regulatory enquiries and prompt response to the customer.
  • Support customer documentation. Handling Quality Complaints.
  • Coordinate for analytical testing and review of results.
  • Co-ordinate with third party as well as in house testing lab for priority analysis.
  • Support local sourcing for identification of right source.
  • Co-ordinate for Import and Export for handling Technical and Quality query.
  • Lead ISO 9001 certification.
  • Candidate Requirement :

    Education & Experience levels :

  • 4 5 Years' Experience in Quality Assurance of Pharmaceutical industry
  • Post Graduate degree in Science (Chemistry).
  • Nature of experience :

  • Good Knowledge in Quality Assurance documentation and Regulatory (FDA) requirement.
  • Excellent communication and organizational skills, with experience working with cross functional departments.
  • Experience in Quality control and conversant with different Analytical techniques.
  • Experience in SAP operation.
  • Knowledge Required :

  • Good knowledge about cGMP requirement as per different Regulatory guidelines, national as well as International authorities.
  • Well conversant with cGMP Documentation requirement.
  • Knowledge about different Pharmacopeias, their requirements, analytical standard and guideline.
  • Different Analytical Techniques used in analysis and Hand on experience on analytical instrument. Knowledge about ISO 9001 certification.
  • Skills :

  • Effective time management, couple with the ability to manage multiple tasks concurrently
  • Excellent communication and organizational skills, with experience working with cross functional departments.
  • Thermo Fisher Scientific is an EEO / Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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