Sr. Executive/ Assistant Manager – QA

Tcggreenchemmfg; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Tcggreenchemmfg in Hyderabad seeks a Sr. Executive/Assistant Manager to oversee QA activities during upgradation and process improvements. The role emphasizes investigations, CAPA closure, and meticulous documentation across QA, production, maintenance and warehouse systems.

The incumbent will lead internal audits, vendor assessments and regulatory interactions, ensuring cgmp compliance and a robust quality framework within the site operations.

Qualifications

• M.Sc Chemistry (Analytical / Organic) is required.
• Strong drafting skills for investigations, responses and compliance.
• Sound command of English, both written and spoken.

Responsibilities

• Execute and coordinate investigations with root-cause analysis and CAPA assignment for quality events.
• Log, review and close change controls and CAPAs, ensuring CAPA effectiveness verification.
• Represent site during regulatory audits and customer inspections; coordinate with inspectors.
• Prepare and review quality risk assessment reports for products and systems.
• Conduct on-the-job training and cGMP trainings.
• Implement and manage documentation systems for QA, production, maintenance and warehouse records.
• Plan and perform internal quality audits and vendor audits for KSMs and packaging materials.
• Coordinate with customers for compliance and day-to-day issues.
• Review and prepare quality agreements.

Education

M.Sc Chemistry (Analytical / Organic)

Job description

To perform the QA activities in view of system upgradation and improvement in the existing procedures.

Job Role:

• 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events.
• 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable.
• 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the Inspectors /Auditors.
• 4. Preparation & review of quality risk assessment reports of products & general systems.
• 5. Conduct on the Job Training and cGMP trainings.
• 6. Implement documentation system to develop, maintain, distribute and control of all Quality Control, Quality Assurance, Production, Maintenance and Warehouse records.
• 7. Planning & execution of internal quality audits and perform vendor audits for the KSMs and packaging materials for vendor qualification.
• 8. Co-ordination with the customer for compliance and day to day issues.
• 9. Quality agreements review and preparation.

Desired attributes :

Technical / Functional :

• Should have exhaustive knowledge on the drafting skills (E.g. Investigations, Responses & compliance).
• Should have sound command on the English with speaking and Writing.
• Sound knowledge of the production operations, QC analytical techniques & facility and maintenance functions.

Behavioral :

Team management, Leadership, Project management, Proactive, Time management and Critical thinker.

Undertaking any other duties which may be assigned as deemed appropriate by the organization

Job Features

Job Category TCG GreenChem Mfg jobs

Position Sr.Executive/ Assistant Manager

Location Hyderabad

Department Quality Assurance

Reports to Head of the Department

Job Code CLIN/QC/12/2024

Job Qualification M.Sc Chemistry (Analytical / Organic)

Experience 10 to 12 yrs. in API plants

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Contact Us

TCG GreenChem Manufacturing Pvt. Ltd.

Anantaram, GummadidalaSanga ReddyHyderabadTelangana, 502313, India

E-mail: [e-mail]

A 100% subsidiary of TCG Lifesciences Pvt. Ltd.

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