Johnson & Johnson Careers
Senior Cell Lead
Requisition ID: 1905741245W
In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently managed and report into their respective Global business segments.
Reports to (Title / Designation): Senior Manager- QCS
- Lead the Stability lab within Stability Operations EMEA/AP – enable analysts to:
- Expand knowledge on stability and related processes
- Be responsible for follow up of incidents and involve relevant parties in solving issues
- Ensure that all the applicable processes and quality systems are followed in the lab
- Responsible for managing workload, daily planning and priorities within Stability lab at APDC
- Responsible for overall quality and compliance concerning stability within Stability lab at APDC
- Responsible for development of scientific level of the stability analysts within the group by continuous improvement projects and coaching and mentoring of analysts.
- Responsible for implementation of and ensuring compliance to the applicable Quality and Compliance policies from Johnson & Johnson, Janssen Supply Chain Global Standards and underlying procedures within Stability lab at APDC
- Responsible for allocating right resources to right jobs.
- Responsible for people development of stability analysts in line with personal and departmental objectives
- Responsible for being spokesperson during internal and external inspection
- Responsible for the activities needed for performing testing within the lab and for efficient functioning of the laboratory
- Follow-up for availability of results and satisfactory closure of events, deviations, CAPA’s and COC’s
- Lead OOS/OOT investigations and lab issues
- Keeping oversight and be accountable for proper disposition of results related to OOS/OOT investigations, which can be done by either performing Level-2, Sign Off in Empower and verification in LIMS system or documenting and approving the results to be reported in Quality record
- Verify that analytical activities are performed according to cGMP requirements
- Ensure availability of necessary equipment, tools, materials for laboratory operations
- Support coordination in the development of guidance and policies with regard to stability. Support implementation of such guidance and policies.
- Ensure implementation of CAPAs and COC’s as per defined timelines
- Keep constant oversight on events, deviations, CAPA’s and COC’s
- Coordinate analytical transfers
- Participate in technical discussions
- Lead escalations linked to OOS/OOT results generated during stability analysis and any other issues linked to lab operations
- Keep close track and oversight on recurrent issues in stability lab and ensure necessary adequate actions are defined to prevent further occurrences
- Emphasize and propagate “Right First Time” approach
- Responsible for the implementation of corrective actions in function of external inspections, internal audits and check rounds etc…
- Guaranteeing application of rules and health, safety, industrial hygiene and environment.
- Preparation and approval of job description of all applicable lab staff and periodic updates of the same.
- Responsible for training analysts in cGMP practices and all applicable procedures.
- Developing training program for the personnel to become qualified in specific areas
- Monitoring the effectiveness of training and providing feedback for continuous improvement
- Setting performance indicators and conducting performance appraisals adhering to company standards
- Setting yearly Goals and Objectives based on the needs for the organization and the individual needs and ensuring alignment of goals and objectives of direct reports to the company objectives
- Recruitment and hiring of lab staff
- Coaching, developing, and mentoring of the lab personnel for individual and organizational development.
- Responsible for development of scientific level of stability analyst within the group by continuous improvement projects and coaching and mentoring of analysts.
- Responsible for self-development and training.
- Responsible for ensuring that equipment are calibrated, maintained and periodically verified as per the pre-established plans/procedures.
- Responsible for ensuring that equipment are re-qualified after changes as per the requirement of procedure and any events/deviations are handled throughout the life cycle.
- Responsible for reviewing Standard Operating Procedures, protocols and operations for qualification, calibration and preventive maintenance
- Responsible to ensure that equipment are calibrated as per applicable Standard Operating Procedure
- Responsible for ensuring compliance to the Validation Master Plan
- Responsible for reviewing and approving the procedures, protocols and other cGMP documents.
- Responsible to ensure that all applicable Global Standards/Global documents, Standard Operating procedures, protocols and other documents are implemented as specified.
- Responsible for ensuring the adequacy and correctness of the procedures as per J&J and regulatory standards and ensuring that the practices as stated in the procedures are followed.
- Responsible for ensuring that documents are archived and retained as per applicable procedures.
- Responsible for the coordination of the work between JSC sites and APDC for planning of analytical testing’s, method transfer and investigations with constant focus on quality and compliance, productivity and customer service.
- Responsible for planning of analytical and other lab activities to ensure timely analysis and reporting of results to customers
- Responsible for allocation of work to trained and qualified personnel and coordination to deliver first pass analysis
- Ensure adequate resources and tools for executing all tasks related to new product introduction strategy, special studies in addition to routine testing, introduction of new customer to APDC stability lab
- Responsible for co-ordination of preventive maintenance of equipment and repairs after breakdown.
- Responsible for ensuring procurements of all related materials of right quality in a timely manner so as to prevent any delays in analysis.
- Responsible for ensuring that any new material introduced in the lab is evaluated for any safety and quality risk.
- Responsible to propose any purchase of material allowing increasing the productivity of laboratories with an aim of reducing the costs of control.
- Responsible for continuous upgrading of knowledge on the technological development of the general instrumentation of the laboratory and propose improvements concerning the existing material as well as new technological orientations.
- Participate in the control of change process at APDC and responsible for proposing and reviewing the changes proposed as per the applicable procedures of the laboratory.
- Responsible for performing impact assessment for the changes proposed within department and on site to ensure that the adequate actions are taken for the impacted areas/processes/systems within stability lab before effective implementation of change.
- Ensure implementation of the approved changed requests for the department in a timely manner.
- Determine training requirements for lab analysts/personnel
- Ensure appropriate workload planning, resources and prioritization of activities to meet departmental commitments
- Maintain lab metrics
- Delegate work assignments / prioritizations of projects
- Handling of events and deviations.
- Ensure performance of analytical activities according to cGMP
- Consults Manager on developmental opportunities for personnel to increase efficiency, encourage job satisfaction and personal growth, and enhance professionalism.
- Translate departmental yearly goals towards the group and the individual group members and evaluate performance of personnel.
- Support introduction of new systems
- Approve job descriptions of employees
- Responsible for implementation of policies laid down by the company.
- Education: Post Graduation in Science
- Experience: 12+ years of relevant experience and 3+ years as people manager
- Other Skills (Certification/s): USFDA and Quality Control
A. Internal Applicants: If you wish to apply, please consider the following information from our Policy:
We require you to have spent at least 18 months in your current position, and in good standing. As our employee, you may apply for a position without informing current manager. However, when invited to interview, then, to the extent that this is consistent with local law or practice, you are required to notify your manager prior to the interview. This notification is reassured to promote development discussions between the managers and our employees.
If you want to refer external talent for this position, please review our Global Referral Policy and submit your referral through My Career Opportunities by following the appropriate process. (Applicable only for Internal postings)
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