Department Details

Role Summary

QA - Regulatory and Customer support

Key Responsibilities

Overall responsible for Regulatory support & compliance

- Collaborate with CFT to ensure compilation & documentation for timely regulatory submissions.
- Develop, maintain & track timelines for regulatory submissions, ensuring that documents are prepared, reviewed, & submitted according to established deadlines.
- Review of analytical data pertaining to various testing of materials
- Review & approval of specifications, MoA, ODS, SOP; validations/verification/qualification & method transfer activities/working,certified & impurity standard Qualification & COAs; floating formats; qualification /re-qualification document/mapping activities; IUT; warehouse discrepancies notes
- Issuance, re conciliation; retrieval & archival activity
- Coordination for APQR activities/ technology transfer activities.
- Coordination with audit management team for completion of audits successfully/risk assessment.
- SCM related activities/requirement/meetings & data preparation.
- Support queries from marketing & SCM functions on product quality & business requirements.
- Assist regulatory science department for product filings.
- Handling of customer queries on analytical data of product/Errata
- Ensure timely completion of training. Review & accept the JD formally presented by the reporting manager.
- Ensure timely & accurate documentation is maintained on principles of GDP & DI
- Addressing the data integrity/GDP non-conformance & escalating to senior management.




- Keep abreast about the roles & responsibility of quality department
- Providing insights for site specific SOPs/corporate
- Issuance, retrieval, archival & destruction of GXP document
- Keep abreast of the quality/EHS policies/procedure adherence & emergency preparedness & response plan.
- Procedural governance for assigning retest date & expiry date for material

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•Ensure that training is completed with successful certification on course before taking up any additional responsibility delegated by reporting manager.

- Arrange relevant supporting documents to provide technical declaration required by customer & RA.
- Fill the questionnaires provided by the customers & RA department & to provide the related supporting documents
- Co-ordination with CFTs to get the relevant documents & response
- Escalate all nonconformances requiring escalation with relevant information to senior leadership.
- Coordinating with cross function team members for achieving quality requirements..
- Ensuring the promotion of awareness of regulatory & customer requirements in the organization in the site.
- Conduction of GMP rounds/self inspection.

Coordination along with user department to carryout risk assessment and review of identified risks and necessary CAPA to eliminate / reduce the risk in a timely effective manner for validation and qualification related activities.

Educational Qualifications

Required Education Qualification: MSc.

Required Experience: 10 - 12 years

📌 Assistant Manager (India)
🏢 BIOCON PHARMA
📍 India