Manager - Formulation & Development DQA

Role & responsibilities

1. Review of documents like Product Development Report (PDR), Master card Manufacturing (MCM), Critical Manufacturing control.
2. Review of QbD documents (QTPP and CQA's, CMA, CPP and Control Strategy) and approval of these documents
3. Experience in the OSD, Topical, Parenteral, Liquid oral and Complex dosage forms.
4. Training & development Functions, Compliance & handling, as per SOP and Regulatory guidelines
5. Review of lab note books and ensure compliance as GLP and GDP.
6. Review trial sheet for development batch and protocol for various studies during formulation and development of product.
7. Reviewing of documents of pertaining to in process, finish product and shelf life specification for RM / Finished product.
8. Review, justifications & response for Market complain or Regulated queries
9. To ensure the IQ, OQ, PQ and calibration related activity for different equipment. Also Review of protocol and report of various PQ documents for different equipment.
10. Knowledge of internal audits for compliance to policies and procedures. Conducting periodic training to ensure compliance with respect to audit observation and effective implementation of CAPA.

Preferred candidate profile

Good in Communication & team handling skills.

Perks and benefits