Pregna International Limited Drug Regulatory Affairs Jobs in Daman | Medical Writing Vacancies

Medical Writing Jobs in Pregna International Limited Daman

Pregna International Limited is accepting applications for 1 Medical Writing vacancies at Daman Location. Candidates who have completed MS/M.Sc(Science) in Chemistry and have required skill set can apply for these Drug Regulatory Affairs Jobs. The company has posted this notification on its website on 7/14/2021. Here one can check the complete details of this Medical Writing Job Openings in Daman like skills required, roles and responsibilities.

Drug Regulatory Affairs Jobs in Daman

To apply for this position, the required working experience is 5 – 10 years. Pregna International Limited is looking for some enthusiastic and talented candidates to work as Medical Writing. So, eligible aspirants can apply for these Drug Regulatory Affairs jobs in Daman via pregna.com. When it comes to Medical Writing Jobs in Daman for Experienced or Graduates, every company requires a specific skill set. As per the requirement of Pregna International Limited, the candidates must have the below mentioned skills.

Complete Details of the Pregna International Limited Drug Regulatory Affairs Jobs

Name of the Hiring Company: Pregna International Limited

Job Role: Medical Writing

Job Openings: 1

Location: Daman

Experience Required: 5 – 10 years

Salary: Rs. 50000 – Rs. 66000

Education: MS/M.Sc(Science) in Chemistry

Job Type: Full Time

Last Date: Not Mentioned

Selection Process: Interview

Medical Writing Job Description

1. Reviewing completed batch production and laboratory control record of critical process steps before release of Batch

2. Ensure that critical deviations are investigated and resolved

3. Ensure validation of analytical methods are conducted, studies of suitability of pharmacopoeia methods, equipment qualification and calibration of analytical instruments

4. Preparation and Review of Validation protocols and reports

5. Ensure that quality related complaints are investigated and resolved

6. To review product quality review

7. To review of the checklist and packing list to for on time dispatch.

8. To review of the Artwork as per customer and regulatory requirements.

9. To represent the team during audits and to comply the observations.

10. To provide documents for the dossier as per marketing need.

11. To apply and maintain the licensing status of the plant, to communicate with FDA as per need.

12. To conduct job related training for subordinates and ensuring the documentation & job description. To contribute in meeting the quality standards by ensuring that all tests and analysis of samples are carried out in time to meet the laid down specification and meet the customer requirement. cGMP and regulatory requirements are fully implemented

13. To review all specifications, sampling instructions, test methods and analytical determinations. SOPs, MFR, BMR, QM. SMF, etc

About Pregna International Limited

Pregna is a worldwide name when it comes to manufacturing as well as delivering high-quality IUDs to women who wish to remain safe from unwanted or unplanned pregnancy. Offering a wide range of intrauterine devices, Pregna serves to be a one-stop solution for women who wish to remain stress-free every now & then about getting pregnant. Right from the copper IUDs , hormonal IUDs or, Tubal rings you will come across a huge collection of high-grade intrauterine devices at Pregna for ensuring long-term family planning.

Required Skills for Medical Writing job

1 ) Qualification: Minimum graduate in Pharmacy/Chemistry/Science stream

2) Experience: Minimum 5 to 10 Yrs at QA department in reputed Pharma/Medical Device
company.

3) Skills: Fluency in English, Good Communication Skills

Medical Writing Roles & Responsibilities

1. To make sure that critical deviation, change control & customer complaint are investigated, addressed and closed accordingly with necessary corrective & preventive action

2. Conduct Vender Audit and assessments as per planner. Ensure that the analysis carried out by contract are reliable.

3. To prepare compliance reports for external audits in co-ordination with different departments

4. To support for document preparation and review the qualification protocols and reports (DQ, IQ, OQ and PQ)

5. Establish and maintain policy for documentation of products.

6. To participate in training a team of skilled staff and to promote healthy working relationships within the organization.

7. Control of all Companies Quality Documents Deviation control, change control, Investigation of OOS, Specification, SOP, and BMR. To inform customers /Regulatory agencies in case of any major process change

8. Market complaint & investigation, return goods records, Corrective and Preventive action (CAPA) is developed and implemented to avoid re-occurrence.

9. Coordinate and Participate in internal and external audit and make sure CAPA is developed and implemented for Audit compliance.

How to apply for Drug Regulatory Affairs jobs in Daman Pregna International Limited?

  • Visit official website of Pregna International Limited i.e., pregna.com.
  • Go to Careers Page.
  • Click on Medical Writing post.
  • Once refer all the job details and then click on Apply button.
  • Now, fill the required fields and upload your Resume, if required.
  • Further updates regarding the interview will be communicated through E-mail or Phone.

Apply Now

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