Pharma QA Executive

4 weeks ago

Ahmedabad, India Whiteice Network Full time

**Pharma QA Executive (Tablets Manufacturer) - WNCPQAE03012023**
- Review and approval of completed Batch Record Sheets and Cleaning Record Sheets.
- Perform batch record review of API.
- Responsible for the release of intermediates.
- Review of SOPs/master batch records / specifications / laboratory methods and GMP related documents as per regulatory filings and GMP requirements.
- Communication with shop floor people e.g. to clarify comments in batch record sheets.
- Management of Change Controls as quality coordinator, responsible for review of changes, doing quality assessment, tracking for completion and closure of change controls.
- Deviation investigation, report writing and CAPA implementation tracking.
- SAP administrator for SAP-QM Module e.g. inspection plan, CoA, MIC etc.
- Preparation of Annual Product Review.
- Conduct self-inspection of facilities, operations and procedures to assure conformance with GMPs and related regulatory requirements.
- Qualification, approval and audit of suppliers of raw materials, packaging materials, ancillary materials, contract manufacturers and contract testing laboratories to assure they can supply products that meet established requirements.
- Ensure safe working by practising and communicating safety.
- Validation and qualification: person should have experience of handling: Design qualification, Installation Qualification, Operational qualification and performance qualifications for facility and equipment.
- Cleaning validation: Person should have experience managing cleaning validations, writing cleaning validation protocols, and defining cleaning limits.
- Quality risk assessment.
- Trending: Data collection and statistical analysis.
- Other responsibilities that are not included in the above but are related to quality assurance and in accordance with internal guidelines and SOP.
- Quality Assurance manager for Pharmaceuticals formulation plant ( Tablets and capsules)
- To maintain and control an overall quality management system documentation.
- Responsible for the preparation planning, coordination and execution of QA training programme.
- Assessment of other departments' training.
- WHO-GMP documentation.
- Issuance of batch number, batch manufacturing record, Register, SOP's, format, protocols, Analytical protocols to departments.
- To review the Analytical records, Batch manufacturing record and batch packaging record.
- Preparation of QA-SOPs, Validation protocol aPQR, summary reports based on the Analytical results and Batch documents data.
- To coordinate for the validation activities with other departments for successful completion.
- Submit customer questionnaires along with declarations, management of free samples.
- Maintaining vendor approval process.
- Daily assessment of site to ensure GMP compliance level of site through round.
- Management of regulatory and customer audit at site.
- Management of Deviation, Incident. Change control, OOS, Recall, Market complaint, Investigation, CAPA, Risk assessment etc.
- Interpretation of sales order and overall management of dispatch.
- Reviewing stability data and sharing inference with management.
- Providing data to Regulatory patents or any other authorities.

**Key Skills**
- Hands-on experience in analytical methodologies such as HPLC, GC, AA, FTIR etc is preferred.
- Good knowledge of FDA regulations and cGMP is required.
- Fluent in English.
- Export Experience in Pharmaceutical Companies.
- Able to work under pressure.
- Excellent Customer focus - teamwork - flexibility - communication with others - negotiation skills - problem-solving - creativity and innovation.

**Salary**

**Industry**

Pharma Tablets Manufacturing Industry

**Education**

**Experience**

Minimum 3 to 5 years of experience as an **Pharma QA Executive in (Tablet Division) **can apply.

**Location**

Ahmedabad - Gujarat

**How to Apply**

Call us on mention numbers OR Mail Us with the Subject Line **Pharma QA Executive**

If you are eligible for this requirement then please message us on our

**WhatsApp Number **
+91-XXXXXXXXXX with your updated resume.

**Support Team,**

**Whiteice Network | 360° Recruitment Service Provider**

whiteicenetwork.in | #whiteicenetwork

WhatsApp Number:
+91-XXXXXXXXXX

PLEASE DON'T CHANGE THE MAIL SUBJECT LINE WHILE FORWARDING YOUR RESUME.

Also, kindly forward this mail to someone who might be interested in the

same & references are also welcome.

**NOTE**: IF NOT MATCHING TO YOUR CURRENT PROFILE THEN KINDLY DO NOT REPLY

**Salary**: ₹40,000.00 - ₹90,000.00 per month

Schedule:

- Day shift

Ability to commute/relocate:

- Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**
+91
+91-XXXXXXXXXX

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