Novartis was created in 1996 through a merger of Ciba-Geigy and Sandoz. Novartis and its predecessor companies trace roots back more than 250 years, with a rich history of developing innovative products. From beginnings in the production of synthetic fabric dyes, the companies that eventually became Novartis branched out into producing chemicals and ultimately pharmaceuticals.
Job Title: Quality Project Specialist
Job IDÂ : 219122BR
Work Location : Hyderabad
Division : Global Drug Development
Job Description:
Position Purpose :Â
Support the timely release of GMP relevant documents and batches. Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with cGMP in TRD.
Major AccountabilitiesÂ
1. Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility.
2. Write and review GMP-relevant deliverables and or/ related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
3. Support project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities
4. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance’s, SOPs etc.).
Additional specific tasks Area of responsibility (mandatory)
a. QA Operations
b. Qualification, Validation, and e-Compliance
c. Compliance
d. 3rd Party Management QA
e. Drug Supply Management QA Specifics – Review of batch records and preparation of release decision -Approve qualification & validation documents – specific key responsibilities (e.g. SOP Manager, Training Admin, Complaint Officer, etc.) -Release consumables – SME functions (e.g. Cleaning validation, Qualification, etc.) -representative or participant in networks, work streams etc.
Key Performance IndicatorÂ
1. In accordance with departmental objectives such as support of projects with agreed quality and delivery dates, passing of internal and external inspections.
2. Maintain sound working relationship with internal customers and external part-ners.
3. Meet quality and timelines in area of responsibility.
4. Feedback from team members.
5. Act in accordance with Novartis standards in particular; cGMP, ethical, health safety and environment (HSE), and information security (ISEC).
Requirements:
- Minimum: Basic degree in laboratory, manufacturing or relevant discipline (apprenticeship or equivalent)
- Desirable: Basic degree in science of relevant discipline (B.A., B.Sc. or equivalent)
- Relevant working experience (min. 1 – 3 years) in TRD, production, QC or QA.
- Communication skills to sufficiently address GMP and logistic related questions with the line unit experts.
- Scientific, technical and regulatory knowledge in a specific area. Basic knowledge of drug development.
- Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.
- Good organizational skills.
- Ability to analyze and evaluate GMP compliance. Detail-oriented individual.
- Knowledge and flexibility to work with relevant IT systems.
