GVK Biosciences is leading Informatics Services provider with wide range of Products and Services across the R&D value chain. Considered a market leader in the development of MANUALLY curated databases, GVK BIOs databases on SAR, PK/Tox and other areas are widely used in the industry and their utility have been well documented in the scientific literature.
Post : QA Executive
Job Responsibilities
To handle validation activities :
- Preparation of Method Transfer activities, Review of Stabilitydata and SOPs, Specifications, MOAs, ATR and Raw data.
- Prepare and seek approval of process & drying validation protocols and their reports
- Preparation and review Quality control specification, MOA,protocols & Photo stability protocols
- Issuance and review of Batch Manufacturing Record and equipment cleaning records and QC department Specification, MOA& Raw data.
- Ability to conductonline(self-inspection)audits in accordance with SOPs
- Archiving of documents like validation protocols, validation reports, validation BMRs, specification & MOA
- Act as point of contact for archival of obsolete documents
- Preparation of Annual Review Reports.
- Zero deviation from SOPs/ norms/ regulatory requirements & escalate deviations (if any)
Ensure Good Documentation Practices (GDPs) :
- Accurate & up-to-date technical documents in accordance with regulatory compliance
- Archival & retrieval of documents
- Prepare / review documents / reports as maybe required
Maintain records, data integrity & safety :
1. Maintain strict data integrity and adhere to all related policies
2. Understand & adhere to safety norms
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Ensure skill development of self:
1) Enhance knowledge in the work area through formal and informal means of learning
2) Focus on developing behavioral competencies through behavioral workshops and feedback discussion with manager
Additional Information:
Exp: 3 – 6 years
Education: M.Sc./M.Pharm.-Chemistry (Organic/Analytical)
Industry Type: Pharma/ Biotech/Clinical Research
Division: Inogent – API
Job Function: Quality Assurance
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