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Deputy Manager - Quality Assurance at Piramal

Medak, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

20 Feb, 26

Salary

0.0

Posted On

22 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Pharmacovigilance, Document Control, Risk Assessment, Impact Assessment, SOP Management, GMP Compliance, Archival Management, Analytical Reports, Trend Analysis, Customer Audits, Compliance Reports, Process Verification, Adverse Event Handling, Specification Management, Quality Complaint Handling

Industry

Financial Services

Description

Preparation, Review & approval of investigation reports, risk assessment, impact assessment reports and other documents as an when required. Handling of product quality complaint (Adverse Event) related to Pharmacovigilance and market complaint investigations in CHEX system as per procedure in co-ordination with Pharmacovigilance team for adverse events as applicable. Handling of ENSUR system for issuance & retrieval of SOPs, specification, ATRs, work sheet & stability protocol management, BMR, BPR, BFR as on when required. Ensure the document control, archival, retention and destruction as defined in the procedure as and when required. Master and obsolete copies management for SOPs, specification, ATRs, work sheet & stability protocol, BMR, BFR, BPR etc. Tracking of SOPs, procedures, specifications etc. for revision as per the validity period. Responsible for archival management i.e. Archival and retrieval of documents as on when required. Review the quality system documents such are protocols, reports, procedures, APQR, trend analysis reports, continual process verification reports etc. as on when required. Sharing the documents to the RA department for filing updation based on change control implementation. Preparation, review of customer, external audits compliance reports etc. Review and approval of analytical reports such are batch analysis, standards, stability study etc. GMP verification and compliance review. Comply with SHE Guidelines, SHE Rules and Regulations comply with usage of PPE wherever applicable.

Responsibilities

The Deputy Manager - Quality Assurance is responsible for the preparation, review, and approval of various quality assurance documents and handling product quality complaints. This role also involves managing document control processes and ensuring compliance with GMP and SHE guidelines.