Online Apply At Johnson & Johnson Recruitment for QA Specialist

 Johnson & Johnson Private Limited Hiring 2022 Degree or Master in Pharmacy/ Science  for QA Specialist At Bangalore, India. Johnson & Johnson Private Limited Notification full details below..Interested and eligible candidates can Apply Now.

• Vacancy details:

• Post Name: QA Specialist

• Qualification: Degree or Master in Pharmacy/ Science  

• Experienced: A Minimum experience of 8+ years

Job Description: Johnson & Johnson Private Limited Hiring For QA Specialist ! 

• Important Details :

• Post of date:15/07/2022
• Location: Bangalore, India
• Selection Process: The selection will be on the basis of Interview.

Roles and Responsibilities

Objectives and Responsibilities

• To oversee the quality and compliance activities of Janssen India for corporate and external manufacturing sites. To ensure that the product quality and safety requirements are met in compliance to local regulatory and J&J corporate guidelines and thereby complying the responsibility towards patients, customers, regulators, society and colleagues.

• Responsible for quality at strategic partner for Janssen (Recipharm Pharmaservices, Bangalore)

• Management of issues escalations, investigations, corrections and preventions.

• Support the launch of Sirturo tablets for various submissions and launches.

• Ensuring all time readiness of EM for regulatory audits. Participated in regulatory audits at EM representing Janssen for Sirturo.

• Providing quality support in development projects like Sirturo pediatric, etc.

• Providing support to Janssen India LOC for management of TrackWise records.

• Plan, participate, and follow up audits, evaluations and technical visits to achieve objectives.

• Influence and build relationships with EMs and other internal parties to achieve objectives.

• Report on EM performance and issues via metrics and reports.

• Ensure compliance with applicable J&J and JSC policy, procedure and guidance.

• Meet personal, EM QA and JSC/ESIQ goals and objectives.

• Undertake consulting, training and improvement projects with EMs to achieve objectives.

• Undertake other projects and duties to support EMs and EM QA objectives as required.

Main Duties/Additional Duties/Sphere of authority

• GxP Compliance at External Manufacturing Sites:

• To support EMs with quality and compliance activities including quality agreements, product disposition, risk assessments, change control, product transfers , product disposition and recalls

• To ensure that all manufacturing, packing operations carried out at external manufacturing site is comply to current good manufacturing practices.

• To ensure that the testing carried out at the existing external manufacturing site laboratories comply to Good Laboratory Practices.

• To ensure that adequate and appropriate quality management systems are established and followed at the external manufacturing sites which meets J&J expectations.

Regulatory Compliance and Applications

• To ensure the status of regulatory compliance at external manufacturing sites is maintained.

• To ensure that the products, packaging components, labeling meet the local & other countries regulatory requirements.

• To ensure compliance with applicable J&J and JSC policy, procedure and guidance.

• To undertake consulting, training and improvement projects with EMs to achieve objectives.

• To plan, participate and follow up audits, evaluations and technical visits to achieve objectives.

Change Management

• To support EMs with quality and compliance activities including change control.

• To ensure that all changes related to J&J products and critical systems at external manufacturing sites and within Janssen are managed through change control system. The changes are assessed for its impact, executed & closed in compliance the regulatory & JnJ requirements.

• To influence and build relationships with EMs and other internal parties to achieve objectives.

Deviation / Non-Conformance Management

• To support EMs with quality and compliance activities including deviations and investigations.

• To ensure that all deviations and non-conformances at external manufacturing sites related to J&J products and critical systems are suitably, scientifically and logically handled, documented, investigated for root cause, assessed for its impact on product quality and safety.

• To ensure that appropriate Corrective actions are taken to mitigate the effect of deviation or non-conformance on the Product and Preventive actions are taken to mitigate the recurrence in future.

Field Action and Escalation Management

• To provide intelligence on EM, regulatory, market related issues.

• To support EMs with quality and compliance activities including, risk assessments and recalls.

• To ensure that all critical product issued are immediately informed to key stakeholders as per JnJ procedure, investigated and resolved to ensure business continuity.

• To collect data from EM, compile in timely manner that is required for investigation based on decisions made in VST, IMT meetings.

Quality Support during Technology Transfer / New Product Development / Validations

• To support EMs with quality and compliance activities including product transfer.

• To extend the quality assurance support during the technology transfer, and other validation activities as required.

To undertake other projects and duties to support EMs for JNJ products, as required.

Annual Product Reviews and Monthly Metrics

• To conduct the review of annual product quality review reports prepared by the external manufacturing sites. To seek the additional data, revision based on review points and identify the actionable points needed based on the APR trend evaluation.

• To report the quality metrics monthly and annually to the quality management.

CAPA Management

• To ensure that all the corrective and preventive actions against any findings noticed during any audit or against any deviation or incidence are appropriately implemented at any external manufacturing site.

• To ensure that the CAPA is implemented timely, tracked for its completion, monitor its effectiveness as per CAPA SOP within Janssen.

Qualifications

Education Qualification

-Degree or Master in Pharmacy/ Science or equivalent education

-A Minimum experience of 8+ years in the field of Quality Assurance Pharmaceuticals

-Experience of Quality systems of all major regulated market.

-Sound experience in Solid Oral Quality operation is preferred.

How to Apply?

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 inspired 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).

How to Apply :

Step 1: Click on below link and you will be redirected to  Career Page of Recruiting Company or Career portal.

Step 2. Register on Career Page of the Company or  Career Portal by giving log in credentials and other personal or education details .

Step 3.Upon successful registration .User need to log in with credentials.

Step 4.Once logged in, User need to fill the all relevant personal ,educational  , Work experience details ,attach resume and submit application form.

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