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 : Lab Operation Manager
Job Description
Lead, manage and accountable for the all lab operation activities and apply scien-tific/technical expertise to address all lab functioning issues for smooth operation of lab in timely manner. Coordinate with all support functions (Line function Oral and Parenteral, Topical and ophthalmic, engineering, HSE, quality, Internal/ external auditors and vendors, lab planner, infrastructure and maintenance) to ensure timely deliverables of assigned pro-jects to PHAD, and contribute to overall GDD, TRD strategies and goals.
1. Lead and manage the lab operational activities to ensure the smooth functioning of the lab and fulfill all related tasks and responsibilities related to lab operation.
2. Proactively resolve the key issues related to laboratory resource and equipment, and any other critical topics in a timely manner.
3. Plan, perform and monitor all assigned activities.
4. Ensure quality and timelines in all assigned lab activities.
5. Ensure compliance to lab operations work according to appropriate SOP’s, GLP, DQP, GMP, OQM, HSE, ISEC and Novartis guidelines.
6. Ensure optimization of lab operational activities and process in assigned projects.
7. Perform risk assessment of critical lab operational activities to ensure the business continuity.
8. Coordinate activities in close collaboration with project teams and peers for vendor management, URS with internal and/or external partners.
9. Coordinate EHS and Quality auditors during facility inspection.
10. Ensure the alignment with line function and lab planner (Oral and PTO) to allocate efficient utilization of resources (FTE and facility).
11. Ensure all own activities aligned with overall lab operational process.
12. Achieving Quality Metric targets and financial targets
13. Measurable contributions to increasing efficiency and productivity in the work related to assigned lab operational activity.
14. Maintains and update laboratory equipment performance (IQ, OQ, PQ) for equipment’s.
15. Ensure and maintain working procedures for all equipment’s in Lab and train supporting team and associates on operating procedures.
16. He should have sound knowledge and have hands on experience on IT competencies.
Specific Activities :
1. Accountable and end-to-end responsibility for smooth functioning of the lab operation.
2. Provide efficient procedures and processes for the maintaining of lab function complete-ly.
3. Coordination with line function and planner (Oral and Parenteral, topical and ophthal-mic) and support functions.
4. Coordination with internal/external vendor and regulatory agencies.
5. Ensure maintenance of infrastructure/equipment and required investments.
Lab Operation Lead Specific Activities :
1. Lead all lab operation activities, functioning of lab, governance of quality and safety as-pects, and coordination with support function like engineering, maintenance, Quality as-surance and HSE. Handle lab compliance like internal and external audits individually with end-to-end responsibility of all operational lab activities.
2. Achieving Quality Metric targets and financial targets.
3. Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
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Candidate Profile
Minimum: Masters in pharmaceutical science or engineering background or equivalent Desirable: Ph.D. or Master’s degree in a Pharmaceutical Science/Technology or engineering Languages: Good knowledge of English (oral and written). Desirable knowledge of site language.
Experience/Professional requirement:
1. Successfully demonstrated several years (mini-mum of 10 years) of directly related experience as R &D lab operation or production planning and operation of manufacturing plant.
2. Recognized expertise in a specific area.
3. Proven track record in utilization of equipment’s /instruments for Oral, Parenteral and Topical dosage forms.
4. Thorough knowledge of state-of-art instrumentation/equipment for broad field of lab operations.
5. Thorough understanding of lab operation, regulatory audits in a specific function.
6. Profound lab operation and functioning skills.
7. Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.
8. Strong knowledge of relevant SOP, GLP, DQP, GMP and Novartis regulations and policies.
9. Strong communication skills. Strong presentation skills and scientific/technical writing skills. Advanced coaching skills.
10. May require up to 15% travel
Additional Information:
Experience: 10 years
Location: Hyderabad
Education: M.Pharm, M.Sc, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Lab Operation
Job ID: 238818BR
End Date: 10th May, 2018
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