 | SWARNALATHA B Oct 2 | Executive - Quality Control-Mahad, Maharashtra, India JOB DESCRIPTION - Raw Material, Finished Goods, & Semi Finished Goods analysis.
- Hands-on experience with HPLC, GC, IR, UV, and AAS instruments
- Sampling of RM/PM
- Knowledge of SAP, Word, and Excel
- Knowledge of GLP/ DI / CSV
QUALIFICATIONS Qualification : MSc Executive - QA Medak, Telangana, India JOB DESCRIPTION - Make a validation protocol and report and give training to the persons as per SOP.
- Review of nitrosamine questionnaire and reports.
- Handling of Change Controls, Deviations, OOS, OOT and Market complaint evaluate the risk of these and write the comment for QA review and ensure these are meeting the SOP.
- Handling of market complaints in track wise and investigate as per nature of complaint and intimate to regulatory authority and customer within the time frame.
- Review and co-ordinate to complete the signing of Quality Technical Agreements.
- Support for customer queries, declaration and Questionnaires or Desktop questionnaires.
- Proactive approach, should be applied for review of SOP, BMR, BPR and APQR preparation.
- Responsible for proper planning and depute the person and ensure the label, Seal intact as per the quality agreement before load the material in container.
- Responsible for attending the customer call and answer the question to the customer scientifically. Maintained the customer centricity and OWN IT principle.
- Follow the SOP and work accordingly for the compliance.
- Interact with internal customer for day to day activity and its compliance. Positive approach should be applied with the internal and external customer to finish the work in timely manner.
- Face the external audit and explain the client query in timely manner. Answer to the auditor against the question.
- Handling of return goods. Whenever return goods reached at site after getting the information. Checked the goods and instruct to the respective person to store the material as per storage condition.
- Responsible for the review of new project process development report and if any finding immediately inform to process development group for the compliance as per SOP.
- Responsible for provide the data for regulatory submission and drug license.
- Proactively take a part for local FDA audit and customer audit. Keep documents ready as per the Agenda for the present to the Auditor.
- Time to time interact with the Technical service department and process development group for short out the problem and documented the same.
- Comply with SHE Guidelines, SHE Rules and Regulations.
- Implement emergency control plan.
- Maintain all relevant records under OHSAS & EMS Systems.
- Observe unsafe acts and conditions and take corrective & preventive actions immediately.
- Report and investigate any incident/accident/ near miss/ illness to the superiors.
- Also responsible for the work of senior in the absence of senior.
- Responsible for checking the cleaning, records, responsible for preparation of Quality manuals.
- Comply with SHE Guidelines, SHE Rules and Regulations Comply with usage of PPE wherever applicable.
- Observe unsafe acts and conditions and take corrective & preventive actions immediately,
- Report any incident / accident / near miss / illness to the superiors.
- And any other job as may be assigned to you from time to time.
- Also responsible for the work of his senior in the absence of senior.
QUALIFICATIONS B.Sc / B.Pharma / M.Sc / M.Pharma / B.Tech REQUIRED SKILLS Change Control, CAPA & QMS Process Validation, Equipment Validation, Facility Validation & General Validaton Team Member - Production JOB DESCRIPTION • Performing and Supervision on Production Activities in SPPS. • Control on cleaning activities, control on BMR-BECR documentation. • Verification of resources (raw-materials, clean apparatus-equipment's) required for production. • Raw-material issuance, issuance of Documents. • Safety awareness. • Understanding of GMP environment. • High on energy and go getter attitude. | | | |
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