19 Aug
|
Quality HR Services
|
Ahmedabad
19 Aug
Quality HR Services
Ahmedabad
Sr. Executive/Asst. Manager - QMS
Opening: 1 Nos.
Job ID: 144845
Employment Type: Full Time
Reference:
Work Experience: 5.0 Year(s) To 12.0 Year(s)
CTC Salary: 6.00 LPA TO 10.00 LPA
Function: Production / Quality / Maintenance
Industry: Pharma/Biotech/Clinical Research
Qualification: B.Pharma - Pharmacy; B.Sc - Chemistry; M.Pharma - Pharmacy
Location: Ahmedabad
Posted On: 18th Aug, 2026
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Position: Sr. Executive/Asst. Manager - QMS
Location: Ahmedabad
Experience: 5 - 12 Years
Industries: Pharma
Responsibilities
- Ensure effective implementation of QMS requirements within the Production department.
- Prepare, Review, initiate, investigate, and monitor deviations, incidents, OOS/OOT, change controls, CAPA, and risk assessments related to Production.
- Coordinate with QA, QC, Engineering, Warehouse, and other cross-functional teams for timely investigation and closure of quality events.
- Review and ensure compliance of BMR/BPR, SOPs, logbooks, formats, and other GMP documentation.
- Support preparation and review of Annual Product Quality Review (APQR/PQR) data related to Production.
- Monitor CAPA effectiveness and ensure timely closure of commitments.
- Conduct and support self-inspections, internal audits, customer audits, and regulatory inspections.
- Ensure timely implementation of audit observations and track action plans to closure.
- Participate in QRM/FMEA activities for manufacturing processes, equipment, and quality risks.
- Identify opportunities for process improvement, compliance enhancement, and reduction of recurring deviations.
- Review production trends, deviations, yields, rejections, reconciliation, and other quality-related performance indicators.
- Ensure adherence to data integrity, ALCOA+ principles, GDP, GMP, and documentation practices.
- Provide GMP/QMS training to Production personnel and monitor training effectiveness.
- Support implementation and periodic review of SOPs, Work Instructions, Master Documents, and other controlled documents.
- Ensure timely investigation and closure of market complaints, product quality issues, and regulatory commitments related to manufacturing.
- Maintain QMS trackers, dashboards, and periodic management reports.
- Ensure effective implementation of change management and assessment of changes impacting product quality and regulatory compliance.
- Coordinate with QA for batch review, investigation closure, and product disposition-related activities.
- Promote a strong quality culture and right-first-time approach within Production.
Required Skills
- Strong knowledge of Pharmaceutical QMS and GMP.
- Good investigation and root-cause analysis skills.
- Knowledge of 5 Why, Fishbone, FMEA, CAPA, and risk assessment.
- Valuable documentation and report-writing skills.
- Solid analytical and problem-solving capability.
- Effective coordination with cross-functional teams.
- Good communication and interpersonal skills.
- Ability to manage multiple QMS activities and meet timelines.
- Proficiency in MS Excel, Word, PowerPoint, and QMS/SAP systems.
Required Qualification
- B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry
Salary
- Upto 10.00 LPA
If you are interested in this opening, please send your updated resume via email with the following details:
- Total No. of Years Experience:
- Current CTC:
- Expected CTC:
- Notice Period:
Key Skills: QMS, BMR/BPR, SOPs
Company Profile
It is one of the leading pharma formulation clients of quality HR services.
📌 Sr. Executive/Asst. Manager - QMS (Ahmedabad)
🏢 Quality HR Services
📍 Ahmedabad