Assistant/Deputy Manager-QA(Formulations)
- Aizant
- 8 - 12 years
- Hyderabad
- 22 days ago
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Job Description
Dear All,
Greetings from Aizant Drug Research Solutions!!
Department: Quality Assurance (QA)
Job Title: Assistant Manager / Deputy Manager IPQA & QMS (Formulations)
Experience: 8-12 Years (Formulation Manufacturing)
Location: Hyderabad(Dulapally)
Key Responsibilities:
In-Process Quality Assurance (IPQA)
- Review and monitor manufacturing and packing activities to ensure compliance with approved procedures, BMRs, BPRs, and SOPs.
- Perform line clearance, in-process checks, and stage-wise batch verification during production and packaging operations.
- Verify dispensing, sampling, reconciliation, and yield calculations.
- Review batch manufacturing records and batch packing records for completeness and GMP compliance.
- Monitor environmental conditions and GMP practices in production areas.
- Handle deviations, incidents, change controls, and market complaints related to manufacturing operations.
- Participate in qualification and validation activities including process validation, cleaning validation, and equipment qualification.
- Ensure implementation and effectiveness of CAPA arising from investigations and audits.
Quality Management System (QMS)
- Manage and review deviations, OOS, OOT, incidents, change controls, CAPA, risk assessments, and customer complaints.
- Ensure timely closure of QMS events in compliance with internal procedures and regulatory expectations.
- Review and approve SOPs, specifications, protocols, reports, and quality-related documents.
- Coordinate internal audits, self-inspections, and regulatory audit readiness activities.
- Support regulatory inspections and customer audits by providing documentation and compliance support.
- Monitor quality metrics, trend analysis, and preparation of management review reports.
- Ensure compliance with Data Integrity requirements and ALCOA+ principles.
- Facilitate quality training programs and GMP awareness initiatives across departments.
- Strong understanding of cGMP requirements as per WHO, USFDA, MHRA, EU-GMP, PIC/S, and Schedule M guidelines.
- Knowledge of pharmaceutical quality systems, risk management, and data integrity principles.
- Familiarity with electronic QMS systems and document management systems.
- Good knowledge of formulation manufacturing processes (Tablets, Capsules, Oral Solids, Liquids, etc.).
Note: Interested candidate can share their profiles to ra*************a@ai***t.com
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: AizantLocation(s): Hyderabad
Keyskills: IPQA OSD Solid Orals Cleaning Validation Process Validation Formulation QMS Quality Assurance In Process Quality Assurance Apqr
Aizant
Company ProfileAizant Drug Research Solutions Pvt. Ltd.Aizant is an integrated drug development solutions provider. Aizant was established by experienced pharmaceutical professionals with global exposure.We are a rapidly growing formulation CDMO and CRO with a diverse portfolio of capabilities par...
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