Assistant Manager QC Analytical Development & Drug Regulatory Affairs

Hiring for People Alliance Workforce Private Limited

from 2 to 7 year(s) of Experience
3,00,000 - 4,50,000 P.A.

Job Description

The requirement for Assistant Manager QC Analytical Development & Drug Regulatory Affairs for Pharmaceutical Industry

Job Responsibility

  • Assay, Related Substances, Content, and Chiral method validation analysis as per ICH

guidelines and requirements.

  • Analytical method validation and method development.
  • Preparation of excel sheets for method validation results obtained for all of the above as per ICH

guidelines and requirements.

  • Handled the task of preparing the protocols before starting the validation as per ICH

guidelines and requirements.

  • Record Maintenance: To keep a complete and accurate record of all experiments and results in

form of laboratory notebooks.

  • Support to CRD team in routine analysis.
  • Experience in handling HPLC, UPLC, UV, etc.
  • Finished Product and In process Material Analysis.
  • Raw Material analysis.
  • Working Standard Preparation Analysis.
  • Preparation of Standard Testing Procedure.
  • Analysis of AMV Samples of Tablets and capsules, Injection or Eye drop.
  • Analysis of Stability Samples Tablets, Capsules Eye Drop, Oral Suspension, and injection.
  • Maintain Logbooks according to CGLP.

Technical Skills

  • Handling of Laboratory Instruments like UV /VIS Spectrophotometer (Shimadzu UV- 1700,1800)
  • Handling of HPLC (Shimadzu CHT 2010, LC 2030, Waters- e2695 with Empower 2&3
  • Handling of GC (Agilent 7890A, Shimadzu 2010 plus & 2014
  • Dissolution Apparatus, pH meter, Disintegration Apparatus, Friability Apparatus, Analytical Balance, etc.

For Drug Regulatory Affairs - Pharmaceutical Industry-

In Regulatory Affairs Department:

dossier preparation as per current prescribed guidelines for the national regulatory agency (for semi-regulated market i.e African Countries (Mali, Benin, Togo, Senegal, Cameroon, Congo, Chad, Guinee, Ivory Coast, Sierra Leone, Kenya, Uganda, Tanzania), ASEAN Countries (Cambodia, Myanmar, Philippines, Malaysia, Singapore, Vietnam, Brunei, Indonesia, Laos, Thailand).

ii. Working on Pre & Post-registration of Dossier (compilation and preparation in CTD and ACTD format) and country-specific Dossiers for Yemen, Bolivia, etc.

iii. Preparation of pharmaceutical/product development report as per the requirement based on the prescribed format.

iv. Submission of the notification to the regulatory agency for the post-approval changes.

v. Preparation and review of labeling information for compliance with regulatory requirements.

vi. Variation filings for re-registered products in different countries.

vii. Review and preparation of CMC (chemistry, manufacturing, and control) data for drafting module 3.

viii. Communicating and requesting the documents from the QC/ QA departments and from the plant with manufacturing license/ WHO GMP certificate and COPP.

ix. Review of documents like BMR (batch manufacturing record), MFR (Manufacturing formula record), stability data, Process validation, and analytical data, certificate of analysis, as per the specifications of API and FP (shelf-life specifications and shelf release specifications with their standard testing procedures (STP)).

x. Understanding of ICH Quality and Efficacy guidelines.

xi. Reviewing and understanding the requirements for container closure system (i.e. for primary and secondary packaging materials with standard testing procedures (STP) and standard testing specifications (STS)).

xii. Follow up with the stakeholders to get corrected documents in line with review comments.

xiii. Understand the use of orange data book for finding the use and functions of excipients.

xiv. To prepare and assist in Q and Q (Quantitative and Qualitative) data required for the manufacturing of one tablet, capsule, ointments, gels, lotions, syrups, etc.

xv. To Review the Analytical validation tests and procedures required for the formulation of tablets/ capsules (Dissolution, Disintegration), etc.

xvi. Checking the Stability data (Accelerated Stability data, Long Term Stability Data, Intermediate Stability Data) and the parameter as per the specifications of the finished product.

xvii. Reviewing the DMFs (Drug Master Files) of the API for the Manufacturer information, Certificate of Analysis, Specifications, etc.

xviii. Assisted in responding to the queries generated by the vendor for already sent dossiers and updating the corrected documents for the same.

xix. To file DMF/ANDA with regulatory agencies

If interested Send Updated Resume at Email Id -

Role:Analytical Chemistry Manager

Salary: 3,00,000 - 4,50,000 P.A.

Industry:Pharma, Biotech, Clinical Research

Functional AreaMedical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role CategoryR&D

Employment Type:Full Time, Permanent


UG:B.Sc in Chemistry,B.Pharma in Any Specialization

PG:MS/M.Sc(Science) in Chemistry,M.Pharma in Any Specialization


Company Profile

People Alliance Workforce Private Limited

People Alliance Workforce Private Limited

People Alliance Workforce Private Limited, founded in 2006 is a specialist local and international human Resources company with national coverage in PAN India & international provinces.

People Alliance Workforce Private Limited An ISO 9001:2008, QMS Certified ,TQM based And India's largest multi interest consulting and business services corporation engaging a variety of organizations, institutions and enterprises in diverse industry . People Alliance is the India's leader in innovative workforce solutions, creates and delivers highimpact solutions that enable our clients to achieve their business goals and enhance their competitiveness. With over 15years of experience. These solutions cover an entire range of talent-driven needs from recruitment and assessment,training and development, and RPO&HRPO, to outsourcing and

People Alliance Group began doing business in 2006, offering executive search and recruitment process outsourcing services to our clients. Several years later, we had a vision to establish a single organization that was able to vertically integrate all hiring solutions, a company capable of fulfilling all recruitment and retention needs as well as providing the resources to manage and enhance an organization's most valuable asset - its people. With much thought and preparation, this concept became a reality in June 2009, when People Alliance became. People Alliance Group . Sixteen offices were started under one corporate brand, resulting in a larger, more specialized span of

services to be offered to clients. People Alliance's services now include executive search, recruitment process outsourcing, college recruiting and contract staffing.

With expertise and knowledge that has been gained over 50 years in the search and recruitment industry, People Alliance is now fully equipped to meet any hiring need. Our company is driven by three guiding principles:

1. To be the single source for all hiring needs. There is no longer a need to look to multiple providers in order to fulfill your varied hiring requirements.

2.Build and customize our solutions to meet each client's specific goals, challenges and corporate culture. Each

company has a unique set of needs and we customize our solutions accordingly.

3.Provide our clients with the resources they need to succeed. Your success is just as important to us as our own and,

because of this, we provide companies with the talent and resources that will help them achieve great things.

With a global presence that extends into Asia, Europe and Latin America, People Alliance can successfully meet our

clients' ever-increasing domestic and international hiring requirements. People Alliance has subject-matter experts in

more than 50 industries and our team members are continually learning and training to maintain

their expertise as the market evolves.

People Alliance is the trusted partner of over 500 +clients, and our continued growth proves that our industry knowledge

and passion to provide clients with the best services and talent possible makes us the ultimate choice for innovative

hiring solutions.

Company Info
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Contact Company:People Alliance Workforce Private Limited

Reference Id:Pawf/QC Analytical Development