Specialist, Quality

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About the position

Responsibilities

  • Perform 100% audit of process documents/log books to ensure completeness and accuracy for assigned functional area.
  • Provide coaching and mentoring of Operations personnel regarding documentation completion.
  • Coordinate with Operations to discuss, resolve, and eliminate documentation observations.
  • Conduct GMP walk-through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements.
  • Ensure proper identification of release status and control of materials through maintenance of quarantines in the SAP system.
  • Perform Quality review/approval of new and updated SOPs and CJAs.
  • Assist with training of incoming personnel and ensure compliance with departmental procedures.
  • Participate in departmental communication processes to escalate concerns and best practices.
  • Collaborate with members from other support groups to identify and implement continuous improvement initiatives.
  • Resolve outstanding issues with process documents/log books and GMP walk-through inspection observations.
  • Cross-train to support other functional quality areas including deviation management and inspection support.
  • Complete training to review qualification documents, change requests, and atypical event investigations.
  • Prioritize review of process documents/log books to maximize cycle-time efficiency.
  • Perform SAP transactions required to document Batch Record and Critical Site review.

Requirements

  • Bachelor degree in a scientific or engineering field preferred; candidates with other majors will be considered with relevant experience.
  • At least one year of relevant post-degree work experience in a GMP-related field, including Technical, Engineering, Quality, or Operations.
  • Evidence of leadership skills with good verbal and written communication skills.
  • Effectiveness and creativity in solving technical problems.
  • Attention to detail, flexibility, and awareness of production and quality control problems.
  • Basic understanding of cGMPs and regulatory requirements in the pharmaceutical field.
  • Basic understanding of Microsoft applications (e.g., MS Excel, Outlook, MS Access).
  • Flexibility to support off-shift or weekend schedules, if necessary.

Nice-to-haves

  • Familiarity with vaccine and/or pharmaceutical processing.
  • Experience with manufacturing batch records is strongly preferred.
  • Quality assurance audits or inspection experience in vaccine or pharmaceutical manufacturing is a strong plus.
  • Aseptic gowning experience.

Benefits

  • Health insurance coverage
  • Dental insurance coverage
  • 401k retirement savings plan
  • Paid holidays
  • Flexible scheduling options
  • Professional development opportunities
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About United Kingdom

The United Kingdom is an island nation located on the northwest coast of Europe. The United Kingdom includes the entire island of Great Britain, which includes England, Wales, and Scotland, as well as the northern part of the island of Ireland. The name Great Britain is sometimes used to refer to the United Kingdom as a whole. The capital is London, which is one of the business, financial, and cultural centers of the world. Other major cities are Birmingham, Liverpool, and Manchester in England, Belfast and Londonderry in Northern Ireland, Edinburgh and Glasgow in Scotland, and Swansea and Cardiff in Wales.

Common Interview Questions

  • Tell me about yourself.
  • Walk me through your resume.
  • How did you hear about this position?
  • Why do you want to work at this company?
  • Why do you want this job?
  • Why should we hire you?
  • What can you bring to the company?
  • What are your greatest strengths?
  • What do you consider to be your weaknesses?
  • What is your greatest professional achievement?
  • Tell me about a challenge or conflict you’ve faced at work, and how you dealt with it.
  • Tell me about a time you demonstrated leadership skills.
  • What’s a time you disagreed with a decision that was made at work?
  • Tell me about a time you made a mistake.
  • Tell me about a time you failed.
  • Why are you leaving your current job?
  • Why were you fired?
  • Why was there a gap in your employment?
  • Can you explain why you changed career paths?
  • What’s your current salary?
  • What do you like least about your job?
  • What are you looking for in a new position?
  • What type of work environment do you prefer?
  • What’s your work style?
  • What’s your management style?
  • How would your boss and coworkers describe you?
  • How do you deal with pressure or stressful situations?
  • What do you like to do outside of work?
  • Are you planning on having children?
  • How do you stay organized?
  • How do you prioritize your work?
  • What are you passionate about?
  • What motivates you?
  • What are your pet peeves?
  • How do you like to be managed?
  • Do you consider yourself successful?
  • Where do you see yourself in five years?
  • How do you plan to achieve your career goals?
  • What are your career aspirations?
  • What’s your dream job?
  • What other companies are you interviewing with?
  • What makes you unique?
  • What should I know that’s not on your resume?
  • What would your first few months look like in this role?
  • What are your salary expectations?
  • What do you think we could do better or differently?
  • When can you start?
  • Are you willing to relocate?
  • How many tennis balls can you fit into a limousine?
  • If you were an animal, which one would you want to be?
  • Sell me this pen.
  • Is there anything else you’d like us to know?
  • Do you have any questions for us?

Educational Qualification

Candidates Who Have Passed Graduate or its Equivalent from a Recognized Board or University Are Eligible For this recruitment. Kindly check the Official Notification for more qualification details. Notification Link Is Given Below.

Document Required

Required Documents for This recruitment: Candidate should have these documents before applying online. Candidates are suggested to read the official notification before applying.

  • Qualification certificate with mark sheets.
  • Passport size photographs.
  • Signature.

How to Apply

All the eligible candidates can apply for this job as mentioned below:

  • Read official notification carefully from the official website.
  • Read notification carefully before applying.
  • Fill the application form (link is given below).
  • Attach required documents and passport size photo with signature.
  • Then submit. Done.

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