Jubilant Generics QC Job Opening – Pharma Candidates Apply Now
OFFICER-QUALITY CONTROL
PURPOSE OF THE JOB
Job Context:
Preparation of Specification, Standard Test Procedure, Record of Analysis and Analysis Reports.
Challenges:
- Ensuring proper security and storage of documents during review process
- Proper and consistent identification of all documents through all processes
- Critical oversight regarding document issue
- Data collection and document review
- Consistent labeling which includes identification codes, documentation revision codes, product identification codes etc.
- Keeping documents concise, legible, accurate and traceable
SCOPE & SIZE OF THE ROLE:
(Please indicate key metrics defining the size & scope of the role)
Revenue / Operating Budget :
- Geographical Responsibilities : (Global/International/Country/Area within country)
- Roorkee Plant
- Area of Impact : (Dept. Location / Function or Business / Organisation)
- Production, R&D, Technical Services, Warehouse, DRA, Quality Assurance
KEY ACCOUNTABILITIES
Accountabilities
Scope of work
- Change Control Initiation of change control in case of any revision.
- STP Pharmacopoeial Updation of specification and STPs.
- Review Review and Updation of respective documents received from R&D.
- Documentation Preparation of the documents well in advance before receiving the samples in the laboratory.
- Coordination Co-ordination between other departments like QA, R&D, DRA, PDL, documentation cell to finalize the documents at the earliest.
- Compliance cGMP/GLP compliance
- General Test Procedure Preparation of General test procedure as per current Pharmacopoeia.
- Validation Excel sheet validation
KEY INTERFACES
External Interfaces
Internal Interfaces
- Auditors Local FDA, Regulatory Bodies, Govt. departments Production Warehouse Quality Assurance Technical Services DRA
EDUCATION & EXPERIENCE
Education Qualification (Highest) with target Institution(s): B.Sc / M.Sc. / B.Pharm
Experience Range: 4-6 years
No. of years post Highest Qualification: 4-6 years
Desirable Experience:
4-6 Years of Experience in managing documentation in Quality control department in a 100% export oriented unit. Sound exposure to face regulatory audit like MHRA, USFDA, ANVISA, TGA, MCC etc.
SKILLS REQUIRED
Skills
Description
Proficiency Level
(General Awareness; Working Knowledge; Functional Expert; Mastery)
Functional Skills:
Understanding of all major analytical equipments like HPLC, GC, UV, etc.
Good knowledge of GDP, cGMP, GLP etc.
Good Knowledge of Regulatory guidelines like MHRA, MCC, ANVISA, USFDA, TGA etc.
Sound knowledge on Pharmacopoeia of USP & EP is essential
Exposure to ERP system is essential preferably SAP.
Functional Expert
Behavioral Skills:
Having good analytical skill
Communication & interpersonal skills.
Attention to detail
Ability to facilitate change
Working Knowledge
- General Awareness: Knows the fundamental or general understanding of concepts.
- Working Knowledge: Has broad job knowledge; knows and applies the full range of concepts and practices. Has broad / working knowledge of the subject. Candidate should use these concepts in day to day practices.
- Functional Expert: Candidate is certified functional expert with strong knowledge on concepts.
- Mastery: Candidate is subject matter expert and has command over the subject/ concepts.
Link to Original Notification to apply
Keywords: Officer-Quality Control, Job Posting, Quality Assurance, Regulatory Compliance, Pharmaceutical Industry, Documentation Management. Jubilant Generics QC Job Opening – Pharma Candidates Apply Now. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
