Sr. Executive-Quality
- Meyer Organics
- 6 - 11 years
- Bengaluru
- 9 months ago
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Job Description
Role & responsibilities
- Issuance of Batch manufacturing records for Tablets, Capsules and Liquid department along with ERP authorizations.
- Giving stage wise line clearance in Tablets, Capsules & Liquid manufacturing/packing department in absence of the line QAs.
- Monitoring In-process quality control checks in Tablets, Capsules & Liquid manufacturing/packing department in absence of the line QAs.
- Approval of coding / overprinting details on primary and secondary packaging which includes batch details, License numbers, country related registration numbers etc.
- Preparation of Process Validation protocol, reports, compilations and conclusions.
- Preparation of APQR, Equipment qualification reports, compilations and conclusions.
- Preparation of Flow charts of Tablets/Capsules/Liquid formulations for records and fulfill other registration requirements.
- Packed stock checking of Tablet/Capsule & Liquid finished goods.
- FGTN & FGRN Release in ERP.
- Final approval of BMRs, BPRs & ERP before dispensing and completed BMR reconciliation and receipt of BMRs.
- Preparation & verification of New BMRs & BPRs for all formulations (FLTS).
- Checking the over printing matter of stereos before ordering.
- Checking of export packing lists and relevant sample details.
- Compilation of IPQC datas in the system in coordination with the online QA staffs.
- Interactions with QA-HO for MRP of new products and revisions of existing products & circulating the corresponding e-mails.
- Compilation of CCAs, Deviations, Non-conformance reports received from QA-HO and In-house, investigate root causes and collaborate with relevant departments to implement corrective and preventive actions (CAPAs).
- Interactions with R&D and QA-HO for queries related to the products.
- Any other jobs & responsibility as and when entrusted by Head of the department.
- Plan and Conduct inter departmental audits and to generate the reports accordingly.
- To prepare QA relevant documents and records for new implementations or revisions.
- Inspection of shop floor activities of cross functional departments on daily basis to Ensure adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Good Laboratory practices (GLP) and other regulatory guidelines requirements.
- Provide training to Staff / Employees on Quality procedures, SOPs, CGMP guidelines and best practices to maintain a culture of quality and continuous improvement.
- Receive and document complaints from In-house, customers, QA-HO and regulatory agencies to initiate investigations and to determine root cause or quality issues and to submit detailed complaint closure reports.
- To ensure zero complaints
- Prepare and review of Validation master plan (VMP) and Site master file (SMP)
Preferred candidate profile
Education:- B. Pharmacy/M. Pharmacy
Experience:- 8 to 12 Years (Pharmaceutical Industry)
Location:- Peenya, Bangalore
Perks and benefits
Regards,
Divya S
(Mob. No. 9945544***)
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Other, Role Category: OtherRole: OtherEmployement Type: Full timeContact Details:
Company: Meyer OrganicsLocation(s): Bengaluru+ View Contact
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Meyer Organics
We think harder to make healthcare simple Welcome to MEYER Organics - India's one of the leading pharmaceutical manufacturer, founded in 1982 in technical collaboration with OMEGA - MEYER Ltd., Jersey ( Br. Isles). We are ISO 9001: 2000 certified. Our network is in the domestic as well as exports ma...
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