Specialist,Quality,QA,Sricity
West Pharmaceutical Services
Sri City, Andhra Pradesh, IN
9h ago

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health.

We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges.

We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect.

With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community.

Giving back is in our DNA our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary :

In this role, you will be responsible to support for coordinating on change control, validation, Deviations, Customer complaints, Customer audits, ISO audit and its activities, CAPA, documentation, records updating and SAP master data maintenance & Train team Overall responsible for coordination on calibration of tools and measuring devices.

Essential Duties and Responsibilities :

  • Responsible to implement, monitor and maintain all QMS & ISO 9001, , ISO 14971, ISO 15378 & ISO 13485 etc., requirements.
  • Responsible to support Process and Equipment validation and its documentations.
  • Responsible to support and handle customer audits independently.
  • Responsible for customer related activities Handling of customer questionnaire & updating.
  • Responsible for coordinate for calibration of tools & measuring devices at external source.
  • Responsible for coordination on change control, Validation, Deviations, Customer’s complaints, ISO audits and its activities and CAPA etc.,
  • Responsible for maintenance and setup QM Master data through SAP.
  • Authorized to release (UD) RM, SFG and FG batches through SAP
  • Supervise, assess and monitor performance of subordinates, monitor training needs and provide training & counseling to subordinates where the need arises.
  • Responsible for conducting GMP training to all employees.
  • Responsible to prepare monthly QA & trend reports
  • Responsible to liaise with Supplier on quality matters and non-conformances.
  • Any other duties as assigned by Head of Quality.
  • Quality : The job holder is aware of his / her special responsibility for quality and conducts his / her activities in accordance with the Company quality policy at all times.

  • Ensure that all the documentation is handled in accordance with GMP requirements Ensure that PO / PR are raised according to all applicable financial procedures.
  • Ensure that all operations in your area of responsibilities are compiled as per GMP , ISO 9001, ISO 15378, ISO 14971 & ISO 13485 (as per current version) etc.

    SOI : The job holder of all relevant SOPs as per Company as they are related to the position covered by this Job Description.

    Safety : The job holder is aware of his / her special responsibility towards health and safety in accordance with the company’s safety policy at all times.

  • Proper use of Personal Protective Equipment (PPE). Work safely by not causing unsafe conditions or doing unsafe acts.
  • Lean : Support and contribute actively in Lean sigma programs and activities towards delivery of the set target.

  • Switch off the machinery if it is not operating; or Switch off the lights and air conditioning if you are the last person to leave the premise.
  • Simplify processes and improvements; reduce printing or photocopying; use recycle papers.

    Basic Qualifications :

  • Graduate in science / Engineering with over all 10 years’ experience in QA and QC
  • 3-5 years experience in medical device (sterile) preferred
  • Preferred Knowledge, Skills and Abilities :

  • SAP HANA QM module exposure
  • Exposure in Audits and documentation
  • Knowledge in calibration activities
  • Microsoft Word, Excel and power point handling
  • Knowledge in Documentation and GMP
  • Strong technical ability in understanding manufacturing processes and related topics
  • Travel Requirements :

  • Must be able to travel up to 10% of the time
  • Physical & Mental Requirements :

  • Physically fit & Healthy
  • Must be a team player
  • West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

    If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby westpharma.

    com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and / or a pre-employment drug screening.

    Report this job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Apply
    My Email
    By clicking on "Continue", I give neuvoo consent to process my data and to send me email alerts, as detailed in neuvoo's Privacy Policy . I may withdraw my consent or unsubscribe at any time.
    Continue
    Application form