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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Mumbai, Maharashtra, India

Job Description:

• Lead the CSQ-LAB team in Higi, ensuring quality oversight for the local TDS Analytical Development laboratories Synthetics.
• Ensure operational oversight for the contract labs used by the TDS organization in India
• Ensure operational oversight for the local contract manufacturers
• Ensuring that GMP activities in the external manufacturers, the laboratories and their contractor laboratories are executed in compliance with the regulations for IMP and national and international cGMP requirements.
• Ensure that methods are developed, validated and transferred in line with the global regulations and J&J quality requirements
• Support QP for the certification and release of investigational medicinal products used in worldwide clinical trials so that patient safety & compliance with applicable regulations are warranted.
• This position provides Quality Assurance, Compliance and Management oversight for local External Manufacturers that are involved in development activities and production of clinical batches for all small molecules (DS & DP) and follows the strategic direction and leadership from the Director ECSQ in the selection, development and management of External Manufacturers in India

QA responsibilities:

Quality leadership:

• Ensure that adequate resources are available to support business needs
• Ensure that GMP R&R’s are clearly described for all employees and that the local organisation charts are available
• Manage the quality organization in such a way that the departmental objectives are met
• Support, coach, develop team in reaching their quality, business and personal objectives
• Establish and maintain effective working relationships with the different internal and external business partners to ensure alignment of objectives and deliverables

Operational quality performance

• Act as an expert resource in assessing and maintaining quality and compliance levels
• Continuously challenge the status quo and lead the development and implementation of breakthrough innovative initiatives that deliver sustainable improvement in organisational, quality and compliance performance
• Represent quality on different forums, steering committees, task forces
• Ensure quality oversight of the local operational activities by documented QA approval of GMP documentation and support/participation in the different quality review meetings
• Ensure and manage the implementation and execution of the different quality system processes through effective SOP’s
• Responsible for ensuring that preparation and support is given by QA during external audits and inspections e.g. EMA, FDA, Customer, and internal J&J

Management of quality issues/complaints

• Ensure that deviations/complaints are timely and properly investigated such that the internal and external customer expectations are met
• Support in-depth investigations by providing technical, quality and compliance expertise
• Ensure that adequate CAPA’s are defined for investigations with potential quality impact
• Ensure that deviations/complaints with potential impact on patients and/or product supply are properly escalated

SHE responsibilities

• Outline SHE responsibilities of all employees in job descriptions
• Cascade SHE objectives throughout the organization
• Evaluate SHE aspects in all decision making
• Monitor SHE performance and correct if needed
• Taking the necessary initiatives to promote SHE, encouraging safe behaviour and ownership
• Use and take care of the available protective equipment
• Report immediate accidents, incidents, damage and abnormal, unsafe, unhealthy or environmentally harmful actions and situations to the senior staff
• Contribute to and propose solutions to prevent unsafe, unhealthy and environmentally damaging conditions (e.g. suggestion forms, participation in accident investigation and core committee Prevention).

Qualification:

University degree or equivalent through experience, scientific orientation (pharmaceutical, chemical or biological sciences)

Experience and Skills Required:

• 12 years of experience in the pharmaceutical environment

• In-depth understanding of pharmaceutical product development, method development, qualification, manufacturing, validation, testing, release and distribution processes.

• Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation, legislations related to method development, Clinical Trials and cGMP and GDP regulations (Eudralex, ICH, Ph.

• Eur., USP, FDA, etc) at global, regional and national levels.

• Have been exposed to Health Authority (e.g. EU and FDA) inspections

• Strong analytical thinking, decision-making and leadership skills.

• Excellent verbal and written communication skills to negotiate and communicate with external and internal customers and partners.

• Knowledge of laboratory equipment validation and computerized systems

• Leadership skills

Required Skills:

Analytical Thinking, Clinical Trials, Pharmaceutical Product Development, Quality Management System (QMS) Compliance, Quality Methods

Preferred Skills:

Compliance Management, Consulting, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Succession Planning, Tactical Thinking