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Job opportunity for M.Pharm, MSc as Assistant Manager @ Intas Pharma- Apply Now

Intas Pharma
Pharmacareer

Website Intas Pharma

About Intas Pharma

Intas Pharmaceuticals, a global leader in the pharmaceutical industry, is dedicated to addressing unmet medical needs worldwide. We are on a mission to provide comprehensive, innovative, and affordable medical solutions to improve healthcare outcomes across the globe. To support our ambitious vision, we are actively seeking top-tier professionals who are eager to elevate their careers.

At Intas Pharmaceuticals, we offer a dynamic work environment, opportunities for professional growth, and a chance to make a meaningful impact on global healthcare. If you are passionate, driven, and committed to our vision of advancing healthcare through innovation, we encourage you to apply.

Assistant Manager – QA – 21 CFR Compliance

Join Our Team with 10-12 Years of Experience in Pharmaceutical Quality Assurance

Qualification: M.Pharm / M.Sc

Job Description:

Are you an experienced professional seeking a challenging role in pharmaceutical quality assurance? Join Intas Pharmaceuticals as an Assistant Manager for our QA – 21 CFR Compliance team. We are looking for individuals with a strong background in pharmaceutical quality systems and regulatory compliance. Take a closer look at the responsibilities and qualifications below:

Responsibilities:

  1. Manufacturing and QC Systems: Utilize your expertise to oversee the operation of manufacturing and quality control systems, ensuring compliance with industry standards.
  2. GxP Software/Application: Be the go-to expert for Dl review and technical/operational compliance of GxP software and applications.
  3. Data Integrity: Apply your practical understanding of data integrity requirements for computerized systems to maintain data accuracy and reliability.
  4. Data Governance: Implement and uphold robust data governance and data lifecycle approaches.
  5. Audit Trail and Electronic Data Review: Expertly handle audit trails and electronic data review, along with periodic reviews of computerized systems.
  6. Alarm and Recipe Management: Review alarm management and recipe management processes to enhance efficiency.
  7. Change Control and Incident/Deviation: Lead the review of change control processes and investigations related to computer systems.
  8. IT Processes: Demonstrate a sound understanding of IT processes, including backup, restoration, and user access management.
  9. Computer System Validation: Participate in the review of computer system validation documents.
  10. Enterprise Validation: Gain an added advantage by contributing to the validation of enterprise-level systems (e.g., SAP, QMS, TMS, LIMS, eBMR, L1/L2 integration, SCADA, CDS, Serialization).
  11. Functional Risk Assessment: Conduct Functional Risk Assessment (FRA) and address gaps in CFR/EU non-compliance.
  12. Audit Representation: Represent the team during audits, define responses to observations, and ensure timely closure.
  13. Collaboration: Foster strong interpersonal relationships and collaborate effectively with cross-functional teams.
  14. Communication Skills: Exhibit strong communication skills, both verbal and written, to facilitate effective interactions.

Job Location:

Ahmedabad & Dehradun

Last Date:

25th October 2023

To Apply:

Please send your CV to meghal_desai@intaspharma.com

Join Intas Pharmaceuticals to make a significant impact on pharmaceutical quality assurance and regulatory compliance. Be part of our team, where your experience and expertise will be valued as we work towards our mission of enhancing healthcare worldwide.

To apply for this job please visit intaspharma.com.