Assistant Executive - CQA

Job Context and Purpose:

The associate will be responsible for the following activities:

- Quality Management system, Document management system

- To roll out & control Internal Audit plan

- To carry out Vendor qualification as per plan

- Support qualification & validation activities for new projects

- Strengthen Quality Management Systems

Key Educational Qualification:

Education: M. Sc

Experience: 2 -39 years in QMS, DMS, GDP, Pharma concept, worked with Projects team, Qualification & Validation, Internal Audits, Vendor Management, Chemical & Microbial testing, Facilitate training

Industry: Pharmaceutical / Pharma Packaging / Food Industry / Healthcare

Targeted Organizations: Pharmaceutical

Level Specific Accountabilities:

Day to Day Work:

A) Implementation of QMS & DMS software

- To strengthen documentation system Implementation of QMS & DMS at all capsule manufacturing location

- Preparation of SOPs, Protocols, Batch Manufacturing Record (BMR), Batch Packing Record (BPR) & other documents

- To create, monitor & review QMS

- Verification of QMS compliance

B) Internal Audit

- Preparation of Internal audit schedules

- Carry out internal audits as per schedule

- Follow up audit &Tracking of CAPA

- Escalate critical observations to Management

- Closing of audits

- Verification of compliances

- Compilation of audit observations and sharing with respective stakeholders

C) Vendor Qualification.

- Preparation of vendor qualification calendar & schedules

- Carry out vendor qualification as per plan

- Escalate critical observations to Sr. Management

- Follow up of audit & tracking of CAPA

- Compilation of audit observations and sharing with respective stakeholders

- Closure of audit

- Creation & maintenance of approved vendor list at central location

C) Qualification & Validation

- Preparation of qualification protocols

- Hand holding of associates to roll out validation activity

- Review of validation report

- Track & ensure validation activity is in line with Validation Master Plan (VMP)

- Support to validation team

D) Quality Management Systems

- Design & improve QMS in line with applicable regulatory standards

- Collect and collate data on quality matrix

- Integrate risk based approach to QMS

- Design quality matrix and track mechanism

- Creation of QMS SOPs and to ensure its control

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