Manager - Quality Assurance - Chemicals Manufacturing Firm

Manager-Quality Assurance @ SRF Ltd. (Chemicals Manufacturing Division), Bhiwadi

Position Name : Manager - QA

Purpose of the role : Lead and implement Quality Assurance by developing the system in line with ICH Q guidelines for Speciality Chemicals Business.

Accountabilities & Responsibilities :

To establish QA system as per guidelines of ISO 9001 and cGMP - ICH Q

1. To train the stakeholders, juniors to establish and implement QA systems fully in line with cGMP - ICH Q guidelines.

2. To establish the concept of Validations, Qualification of Equipment- s and review the reports submitted by stakeholders

3. To establish stability study program and monitor the effectiveness through periodical review with QC data

4. To facilitate the analysis of Risk wrt Quality in line with ICH Q guideline

5. To facilitate the analysis of Risk wrt Quality in line with ICH Q guideline

6. To ensure regular audits are performed through IP QA and system is improved by implementing CAPA

Compliance with global standards :

- Ensure the compliances of Quality and Regulatory requirements of products supplied in line with customer reqts - ICH Q, QMS, NABL guidelines

- Timely response to customer complaints To respond timely for customer complaints by submitting CAPA reports

- Timely response to customer questionnaires and agreements To review, approve and respond timely to customer questionnaires and quality agreements

- Effectiveness of documentation, change control, deviation control To review, approve and control all system SOPs, track the effectiveness of change control, deviations like NCPs, OOS, OOT, OOC

- Continual Improvement To facilitate the analysis of various Mfg and QC data and coordinate with stakeholders to simplify the processes basis the trend of performance

- Vendor audits / development To lead vendor audit, qualification and evaluation process in line with plan agreed with Sourcing

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