Elanco QA Advisor Role Available
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Elanco QA Advisor Role Available – Apply Online

IN – Bangalore

Time Type: Full Time

Posted On: Posted Today

Job Requisition ID: R0020616

Position Description:

Provides Quality Leadership and GMP Compliance Guidance for global R&D functions, Project teams and thereby supports new global product development, registrations, licensing, technical transfers, and product launches.

This position develops strong partnerships and positively influences the various R&D functions, Project teams, and CMOs to provide guidance and support on overall quality strategy and to meet requirements of both Elanco and applicable regulatory authorities.

Proactively seeks solutions to lead and drive quality compliance through implementation, monitoring, and improvement of Elanco Quality Systems, training, and compliance tools, with expert focus on Technical Development activities.

Functions, Duties, Tasks:

  1. Provides Quality Leadership to R&D functions and project teams at a global level. Assures adequately trained and knowledgeable quality resources are available to support R&D for projects assigned.
  2. Drives Quality Excellence in Global R&D and QA teams with expert focus on cGMP and non-regulated oversight. Develops and executes components of Quality plan, self-inspection and supports Quality metrics together with business functions.
  3. Independently evaluates scientific, business, and quality aspects of global projects and procedures to positively influence business partners and outcomes. Recognized as an expert in quality compliance for non-regulated, cGMP, and proficient in other regulated areas such as Quality Management Systems.
  4. Builds strong relationships with internal and external business partners in R&D, TS/MS, CMOs/TPOs, and Quality. Interacts with customers, regulators, and outside stakeholders.
  5. Applies depth and/or breadth of technical experience and scientific knowledge to find customer-oriented and fit-for-purpose solutions for projects and process challenges around quality issues.
  6. Sets overall quality and compliance strategy for R&D projects in consultation with the project teams. Provides guidance to and supports the project teams throughout the entire development program.
  7. Scientific and compliance review and approval of GxP documentation for manufacturing and registration including but not limited to pre-clinical, clinical, and CMC protocols and reports.
  8. Provides and develops quality and compliance training for R&D teams.
  9. Responsible for compliance audits and QA oversight at the local site, for global R&D, and for GxP qualification and oversight activities at third parties. Issues self-inspection reports and reviews & approves responses and corrective & preventive actions (CAPAs).
  10. Coordinates preparation activities for regulatory authority inspections with the business partners, site QA, and Global Quality Compliance & Auditing (EGQCA) to ensure inspection readiness at the site. Supports R&D in new third-party (CMO, CRO) or supplier selection and approval qualifications (audits).
  11. Responsible for maintenance (initiation, review, renewal, etc.) of Quality Agreements with third parties for development activities where required.
  12. Responsible for releasing investigation material (drug substance, drug product, etc.) and other development materials as per Elanco Quality requirements. Trains others to do so as delegates.
  13. Complies with all company local and global policies, including all Elanco Global Quality Standards, Elanco Ethics and Compliance, and HSE policies.
  14. Performs any other duties or serves in such other capacity as may be determined by Company Management.

Minimum Qualification (education, experience, and/or training, required certifications):

Education: Ph.D. in Life Sciences or similar degree and/or relevant equivalent experience in Technical Area (Pharmacy, Biology, Biotechnology, Chemistry).

Experience:

  • Greater than 5 years’ experience in Quality Assurance, Quality Control, or related technical field (Pharmaceutical Development, Manufacturing, Chemical Engineering, etc.).
  • Experience in vaccine/animal health, biotherapeutic (large molecule) development experience, with R&D-related Quality Assurance.
  • Strong background in pharmaceutical manufacturing and/or R&D.
  • Excellent English communication skills, verbal and written.
  • Expert knowledge in several of the following: GMP, compliance in one or more global regulatory requirements (EMA, FDA/CVM, MHRA/VMD) as well as in regulatory submissions.
  • Experience with Quality Systems, processes, and training.
  • Knowledge of PC tools, including all MS Office applications and Internet.
  • Ability to set priorities and manage multiple tasks.
  • Effective interpersonal and team-building skills, ability to influence without authority to drive favorable outcomes while maintaining positive working relationships.
  • Ability to interpret regulations & policies and to make recommendations.
  • Solid project leadership skills, ability to work effectively with teams.
  • Strong analytical skills: can define problems, collect and review information & data, and draw valid conclusions.

Additional Preferences:

  • Fluent in English.
  • Skilled in risk-assessment methodologies.
  • Auditing experience.
  • Advanced certifications and degrees, desired.

APPLY ONLINE HERE

Keywords: Elanco, QA Advisor, Quality Assurance, R&D, GMP compliance, Bangalore. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like TwitterTelegramFacebook and Instagram. Elanco QA Advisor Role Available – Apply Online.

Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.