Career opportunity for Technical Service Expert in Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Technical Service Expert

Job Description
Support QAMs to manage the complaint process which includes work in progress tracking, sending/retrieving information from the managed CMOs, closing minor/recurring complaints, trending and analysis of complaint clusters, AQWA admin support, etc. This role requires adherence to specific cGMP requirements and execution according to the valid SOP’s. Also,
• To execute change control activities (Cat I) according to the global Change Control process.
• To prepare and publish the Change Control KPI’s and Reports.
• Execute assigned tasks from Site Change Coordinators to eliminate overdue change requests
• Guarantee AQWA system data consistency.

- Support all activities related to Complaint handling process within External Supply. Ensuring compliance according to the Novartis internal quality standards, relevant regulatory requirements and the filed product quality standards.
- Work together with and ensure that the respective Quality Assurance Manager is kept regularly informed of all complaints and issues related to the products manufactured at the respective Third Parties.
- Work together with Third Parties to ensure that adequate information required for a timely investigation at a Third Party is provided.
- Perform trend analysis of complaints per SOP to ensure an early detection of trends and the correct implementation of CAPAs as required.
- Create, review and approve quarterly trending reports.
- Assure complete and correct complaint documentation incl. keeping of deadlines (according to local QA KPIs) and GMP-compliance/pro-active follow-up of actions.
- Support compiling templates for minor and major complaints
- Perform and complete investigations for minor, major and recurring cases in a standardized process as directed by the accountable QAM.
- Support providing KPIs for complaints for monthly and annual reports as defined.
- Support weekly, monthly, quarterly, annual tracking related to complaints within External Supply (all regions), including reporting of overdue items and trending. Work together with QAMs and QA Leads to ensure compliance of process.
- To manage Change Control process of Cat I changes according to the global SOP.
- To establish and lead on site project teams for Cat I changes in order to ensure project man-agement according to the agreed strategy and timelines, if required.
- To ensure efficient, timely and clear communication to all involved partners.
- To communicate project progress and deviations as appropriate. To elaborate risk mitigation plans as appropriate. - To solicit input from External Supply Functions and to ensure that site specific information is made available, as required for Cat I changes. - To co-ordinate and ensure timely reviewed documentation. - To ensure that projects are realized/implemented without stock-outs. To ensure that write-off costs are kept to a minimum. - Super user role for Supply Chain SharePoint (updates, maintenance,...) - To guarantee AQWA system data consistence ( Third party names update,...)

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Candidate Profile
(Technical) University/academy degree in chemistry, pharmacy or equivalent. Ph.D. advantageous. English very good knowledge spoken/written
- Preferable: Professional experience in quality control/quality assurance or in the manufacturing of pharmaceutical drug products.
- Entrant from university with Ph.D. possible.
- 2-3 years’ experience (GMP)

Additional Information:
Experience: 2-3 years
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Logistic
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 140505BR
End Date: 30^th October, 2014