Position Associate Global Quality Customer Support
Function Quality Assurance
Location: Hyderabad
Work Time Zone : Shift: EMEA/US Shift (Candidate should be flexible) 12 to 9 pm or 5 to 2 am
Responsibilities:
Coordinate customer requests for Quality Assurance support product regulatory inquiries.
Complete questionnaires and coordinate the requests with regional and global quality team members and product regulatory.
Work closely with internal and external customers to provide communication of the status of requests
Serve as the first point of contact of customer questionnaires and provide appropriate answers.
Own requests to follow up with each case and complete them in a quick and qualified manner.
Understand Quality and regulatory issues for customers in pharmaceuticals, food, and/or personal care, Specialty Chemicals, Excipient environments.
Desired qualification:
Bachelor s Degree or equivalent in Chemistry or a related technical degree
Proficient at speaking, writing, and reading English; other Asian or European languages are a plus
Minimum 4-5 year s experience in Quality Assurance support product regulatory in chemicals, pharmaceuticals, food, and/or personal care, Specialty Chemicals, Excipient for a multinational company
Detail-oriented, excellent organizational and communication skills
Able to work at times corresponding to the European and US work days
Experience required:
4-5 years preferably in Specialty Chemicals, Excipient or Pharmaceutical, Personal Care, industries as part of a QA and product regulatory support inquiries.
Technical Knowledge, Skills & Abilities:
Compliance with Quality and Regulatory Requirements Working knowledge and understanding of Product Quality and regulations, such as QMS systems especially ISO 9001:2008, ISO 9001:2015, ICH Q7, IPEC, cosmetics (PCPC), pharmaceutical, and food.
Communication Skills Ability to communicate across all levels of the organization. Able to clearly and effectively communicate verbal and written appropriate to the audience.
Computer Skills - Working knowledge of current software systems, i.e. SAP, e-mail, Microsoft Office (Outlook, Word, Excel, PowerPoint, SharePoint). Skilled in utilizing database software programs and electronic project management tools.
Leadership Skills & Competencies:
Ethics, Values, Integrity and Trust - Adheres to and practices an appropriate and effective set of core values and beliefs during both good and bad times; Acts in line with those values; Rewards the right values and disapproves of others. Consistently demonstrates and is regarded as having high integrity and trust among peers, managers and employees; is widely trusted and seen as a direct, truthful individual; Keeps confidences and admits mistakes; Doesn't misrepresent him/herself for personal gain
Problem solving - Demonstrate a problem-solving approach when faced with challenging or difficult situations; Uses rigorous logic and methods to solve difficult problems with effective solutions; Probes all fruitful sources for answers; Can see hidden problems; Excels at honest analysis; Looks beyond the obvious and doesn't stop at the first answers
Planning and Organizing - Ability to plan, prioritize, and organize work effectively to produce measurable results. Define objectives and integrate into the organization quickly and smoothly Ability to perform both long and short term planning
Technical Competencies (Knowledge, Skills and Abilities)
Clear understanding of Product Quality Assurance and global regulatory framework regulatory in chemicals, pharmaceuticals, food, and/or personal care, Specialty Chemicals, Excipient for a multinational company) with robust domain knowledge.
Demonstrated familiarity and strengths in performing information searches on Quality Assurance and regulatory and scientific databases (such as PCPC, Ariel, USFDA, chemical inventory etc).
Expert in preparation of standard documentations required for regulatory information and submissions globally.
Experience in drafting SOPs required for day to day working areas
Tracking customer requests and responses.
Manufacturing process knowledge.
Product stability, residual solvent statements. Heavy metals and elemental impurities.
ICH Q7, IPEC and PCPC.
Preparing stander responses to customer.
Understanding and responding to product and plant Quality queries.
Process knowledge in quality operation.
Process knowledge in customer complaints.
,Sapwood Ventures Pvt. Ltd. Company Profile: Sapwood Ventures Pvt. Ltd. We are a leading Manpower Consultancy hiring for our client located in Mumbai, which is a business solution provider.