01 Aug
|
Quality HR India
|
Silvassa
01 Aug
Quality HR India
Silvassa
Job Description:
Position: Executive/Asst. Manager - QA
Location: Silvassa
Experience: 2 - 10 Years
Industries: Pharma
Responsibilities:
Ensure compliance with GMP, regulatory guidelines, and quality standards in pharmaceutical formulation manufacturing.
Manage quality systems, audits, documentation, validations, and batch release while leading the QA team.
Implement and maintain Quality Management Systems (QMS) as per USFDA, WHO-GMP, MHRA, and EU-GMP.
Oversee deviation management, CAPA, change control, and OOS/OOT investigations.
Conduct and lead regulatory and customer audits and ensure compliance with audit observations.
Manage process validation, cleaning validation, and analytical method validation as per regulatory standards.
Maintain data integrity and ensure compliance in reviewing BMR, BPR, COA, and stability studies.
Handle vendor qualification, supplier audits, and raw material compliance.
Lead customer complaint handling, market recalls, and root cause investigations.
Provide GMP training, mentoring, and development of the QA team to drive quality excellence.
Ensure effective coordination with cross-functional teams to maintain quality standards across production and QC.
Required Skills:
Solid knowledge of regulatory compliance, quality risk management, and audit handling.
Expertise in QMS, validation processes, and documentation review.
Excellent leadership, problem-solving, and communication skills.
Exposed to regulatory audits.
Exposed with Sterile / Non-sterile products formulations.
SAP is must
Required Qualification: - B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry
Salary: - Upto 4.20 LPA
If you are interested for this opening please send updated resume on same mail with following details.
Total No. of Years Experience :-
Current CTC :-
Expected CTC :-
Notice Period :-
📌 Executive/asst Manager Qa Silvassa
🏢 Quality HR India
📍 Silvassa