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QA Specialist, External Quality, Janssen Supply Chain

Johnson & Johnson
Location: Hyderabad, Experience: 4 years - 6 years
Posted On: 16-Jan-2022 | Last Date to Apply: 30-Apr-2022 | No: of Vacancies : 1

Company Profile:

: Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We welcome innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every single day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives. In India, J&J operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently handled and report into their respective Global business segments

Job description:

Key Objectives

The Packaging QA specialist for External Quality role is to perform the role of quality oversight for Vaccine External Manufacturing (EM) sites (Drug Product Plant) with the focus on quality oversight of packaging operation i.e. artwork management and secondary material management activities.

This position will work with cross functional teams especially EM QA, RA and TO to coordinate the artwork change and provide quality oversight of packaging opeation of drug product (DP) manufactured at EM site. It is also expected that this position is able to based in the EM site in Hyderabad, India as person in plant.

Main Responsibilities

  • Review batch documentation provided by contract manufacturers (CMO)  and responsible for product release in accordance to Janssen Supply Chain (JSC) procedures
  • Provide quality oversight on secondary operation including labeling, cartoning etc.;
  • Ensure documentation review meets the requirements as specified for each product;
  • Support qualification of suppliers for secondary packaging materials i.e. labels, cartons and other printed materials;
  • Alert Supervision of any nonconforming results, out of trend, or out of specification results. 
  • Support supply chain logistics for on time shipments
  • Complete and pass all applicable training required for access to the systems
  • Complete and pass all applicable training for Good Manufacturing Practice and quality requirement training   

Requirements

Experience expectation

  • Bachelor Degree in a scientific function, or equivalent degree level, with minimum of 4+ yr healthcare industry experience
  • Experience in quality function in Biologics or Vaccine industry preferred
  • Previous experience in work environment under cGMP regulation highly desirable, 
  • Must have strong ability to maintain high efficiencies and accuracy in data entry.
  • Strong proof-reading skills to validate complex information and detect errors
  • Strong quantitative and analytic abilities to analyze and validate data
  • Ability to maintain and organized record file is essential
  • Strong computer skills in Excel, Word, Sharepoint
  • Ability to follow standard operating procedures and work instructions. 
  • Good interpersonal, communication and organization skills. Ability to manage multiple and changing priorities required. 
  • Detail oriented, dependable and motivated
  • Willingness to initiative to alert supervision when encountering aberrant data. 
  • Fluency in English.

Key Qualifications

Bachelors

Education

B.Sc

Skills

quality function in Biologics or Vaccine industry,

Industry

FMCG/Food/Beverage

Gender Preference:

Female

Job Type:

Full Time

Diversity Tags:

Not Applicable