We would like to take this opportunity to introduce Whiteice Network | 360° Recruitment Service Provider as an emerging Recruitment Company based at Ahmedabad - INDIA.
We have a position matching your profile. Requirement is as follows.
Before Applying For This Position, Please Read Full Description Carefully....
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
₹40000/- to ₹90000/- pm (Best in the Industry for Qualified Candidate)
Industry
Pharma Tablets Manufacturing Industry
Age Limit
Maximum 40 Years
Education
Any B Pharm / M Pharm candidate with the knowledge of Pharma Tablets Manufacturing Industry can apply for this position...
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 9510356364 with your updated resume.
Support Team,
Whiteice Network | 360° Recruitment Service Provider
whiteicenetwork.in | whiteicenetwork@gmail.com | #whiteicenetwork
WhatsApp Number: 9510356364
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