Executive Regulatory Affairs @ GSK India

Position Title: Executive- Regulatory Affairs

Department Name / Franchise: SRAQC

Sector: Medical

Position Location: Delhi

Reports to (Title): Manager- RA

Responsibilities/Accountabilities:

- Compilation, review and submissions of Regulatory filings for India

- Ensures compliance with regulatory agency regulations and interpretations Gathers and assembles information, prepares documents for New Product Applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines

- Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations

- Provides regulatory advice to project teams

- Organizes and maintains reports of schedules for new Medical Device applications and Renewal Applications.

- Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines

- Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner

- Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware

Qualifications:

- Post Graduate- LifeScience/ Bio Medical/ Pharmacy

- Minimum 5-6 years Industry Experience in Regulatory Affairs, preferably in medical devices.

- Experience of Submitting, Registering and maintaining Product registrations with MOH

- Experience in quality/ manufacturing and regulatory affairs in medical devices would be advantage

- Experience in assembling product dossiers for submission to Regulatory Authorities.

- Good technical writing skills.

Manager - Quality Job @ GSK India

Janssen, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neurosciences & analgesia, dermatology, infectious diseases and metabolic diseases in India.

Job Title (India Specific): Manager – Quality
Reports To: Director – RA, Quality & Technical
Business Unit: Business Quality, Janssen India
Role Type (IC / Supervisor): Individual Contributor
Job Location: Mumbai

Position Summary: The person would be required to establish, implement and maintain a quality framework that supports key GMP and GDP processes within and across the Local Operating Company. Support local operating company management boards in meeting business and compliance requirements through proactive quality management.

Job Responsibilities
Regulatory Compliance:
- To ensure that the Janssen India products, packaging components, labeling meet the local regulatory requirements
- To ensure that all changes related to J&J products and critical systems at external manufacturing sites and within Janssen India are managed through change control system. The changes are assessed for its impact, executed & closed in compliance the regulatory & corporate requirements.

Deviation /Non-Conformance Management:
- 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; and appropriate Corrective actions are taken to mitigate the effect of deviation or non-conformance on the Product.

Quality, Compliance and SAP transaction of JSC site products imported & sold in India:
- To ensure that the JSC Site products imported in India are released in ERP (SAP System) after satisfactory evaluation of the temperature data (for cold chain products), certificate of analysis, certificate of compliance and health authority test reports (wherever applicable).
- To escalate the issues pertaining to the product, temperature excursion to the JSC Site Quality in event of any product quality or shipment issue via PQMS.

Complaint handling, PQMS and EDGE2 Management:
- To receive, acknowledge, log, investigate, assess the incoming complaints timely. To assess the criticality and impact of the complaint from a quality perspective and timely forward the complaints to the EM and adverse events to the LSO for reconciliation, investigation and closure.
- To update the complaint handling procedure as per current J&J standard and to train the all concerned employees.

Qualifications: At least 10 years’ of relevant experience in Pharma industry. Master of Pharmacy with specialization in Quality Assurance.

Pharmacovigilance Expert Recruitment at Novartis

India Novartis Healthcare Private Limited,

Research & Development,

Pharma-Oncology

Eligibility: Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/ or Medical Degree (MBBS or MD) Good knowledge/fluency in English. Knowledge of other languages desirable. 3-6 years prior experience in clinical research or its equivalent with a minimum of 3 years of drug safety experience preferred. May be a first job in the pharmaceutical industry for an MBBS/MD with 3 years clinical experience postdoctoral Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred. Excellent understanding of clinical trial methodology, GCP and medical terminology. Attention to detail and quality focused. Ability to operate effectively in an international environment. Excellent understanding of physiology, pharmacology, and the drug development process including its interactions with HAs. Strong technical and problem solving skills. Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.

For details visit NOVARTIS JOB

Pharmacist Jobs in CDMO Angul

Office Of Chief District Medical Officer (CDMO), Angul has released notification for the recruitment of Pharmacist vacancies on contractual basis.

Total No. of Posts: 25

1. ST: 08 Posts
2. SC: 04 Posts
3. SEBC: 03 Posts
4. UR: 10 Posts

Age Limit: Candidates age should be between 21-32 years as on the date of advertisement. Age relaxation is applicable 5 years for Women/ SC/ ST/ SEBC, 10 years for PH/ Ex-Servicemen as per rules.

Educational Qualification: Candidates should have passed +2 Science examinations under council of Higher Secondary Education with Odisha/ equivalent & Diploma in Pharmacy froma ny of the three Medical Colleges and Hospitals of the State..

Selection Process: Candidates will be selected based on Career Assessment.

How to Apply: Eligible candidates may send their applications in the prescribed format affixing recent passport size photograph on it by Registered post/ Speed post / Courier on or before 31-07-2015.

Last Date for Submission of Application: 31-07-2015

104 Pharmacist Jobs in CCRAS

Ayurveda Regional Research Institute (ARRI), Central Council for Research in Ayurvedic Sciences (CCRAS) has issued notification for the recruitment of Pharmacists.

Total Vacancies: 104 

a. Gaya (Bihar): 36 Posts

b. Bhilwara (Rajasthan): 46 Posts

c. Surendra Nagar (Gujarat): 22 Posts

Age Limit: Candidates age should be not exceeding 30 years. Age is relaxable in the case of SC/ ST/ OBC as per DOPT instructions.

Educational Qualification: Candidates should possess +2 Science with Diploma in Pharmacy (Ay) or B.Pharmacy and registration with Pharmacy Council of India.

Selection Process: Candidates will be selected based on written test/ interview.

How to Apply: Eligible candidates can send their application in prescribed format along with self attested copy of all testimonials should reach to the Research Officer In-charge, Ayurveda Regional Research Institute (ARRI), ‘D’ Block, Rajindra Memorial Res. Institute Building, Agam Kuan, Patna-800007 within 21 days from the date of advertisement. For details visit www.ccras.nic.in

Date of Advertisement: 21-07-2015. 

Last Date for Submission: With 21 days of advertisement

Pharmacist Jobs at CDMO Jagatsinghpur

Office of the Chief District Medical Officer (CDMO), Jagatsinghpur has advertised a notification for the recruitment of Pharmacist Vacancies on cotractual basis.

Total No. of Vacancies: 10
Name of the Posts: Pharmacist

Age Limit: Candidates age limit is 21-32 years as on the date of advertisement. Age relaxation is 5 years for SC, ST, SEBC & women candidates, 10 years for Physically handicapped/ Ex- Serviceman candidates.

Educational Qualification: Candidates should have passed +2 Science exam under CHSE Odisha/ equivalent and Diploma in Pharmacy from any of 3 Medical College & Hospital of the state / any other recognized private institute duly approved by AICTE and exam conducted by Odisha Pharmacy Board with relevant experience.

Selection Process: Candidates will be selected based on their performance in interview.

How to Apply: Interested candidates can send their application in prescribed format along with attested copies of relevant certificates, attested passport size color photograph, mark sheets, Diploma, Registration, Residence certificates and in an envelope should be superscribed as “Application for the Post of Pharmacist (DDC)”  to Chief District Medical Officer, Jagatsinghpur on or before 29-07-2015.

Last Date for Receipt of Application: 29-07-2015