Openings @ Medley Pharmaceuticals Ltd
Assistant Manager Production (API)-Tarapur / Production Officer (API)- Tarapur /
Experience: 7-12 yrs
Qualification:
B.Pharm / B.Sc / M.Pharm / M.Sc
Job description
1- Responsible for
monthly production planning, Execution & monitoring.
2- Responsible for
all daily operation and production of commercial API.
3- To train all
shift supervisor and operators about unit operations, safety and SOP.
4- Technology
transfer coordinator jointly with R&D & QA.
5- Handle
production QMS documents like Change control, Deviations, OOS.
6- Responsible for
regulatory audits & customer’s audit CAPA & Implementation of CAPAs.
7- Overall
Responsible for Production related SOP, review and implementation at site.
8- Conducting
training for new recruited production chemist in terms of cGMP/ GDP aspects and
Safety aspec
QA Officer (Tarapur)
Experience: 4-8 yrs
Qualification:
B.Pharm / B.Sc
Job description
1.
To maintain and control an overall
quality management system documentation.
2.
Responsible for the preparation
planning, coordination and execution of QA training programme. Assessment of
other departments training
3.
Issuance of batch number, batch
manufacturing record, Register, SOP's, format, protocols, Analytical protocols
to departments
4.
To review the Analytical records, Batch
manufacturing record and batch packing record
5.
Preparation of QA-SOP's, Validation
protocol aPQR, summary reports based on the Analytical results and Batch
documents data.
6.
To coordinate for the validation
activities with other department for successful completion
7.
Submit customer questionnaire along with
declarations, management of free samples.
8.
Maintaining vendor approval process
9.
Daily assessment of site to ensure GMP
compliance level of site through round.
10.Management of regulatory and customer
audit at site
11.Management of Deviation, Incident.
Change control, OOS, Recall, Market complaint, Investigation, CAPA, Risk
assessment etc
12.Interpretation of sales order and
overall management of dispatch
13.Reviewing stability data and sharing
inference with management.
14.Providing data to Regulatory patent or
any other authorities
If you are looking
forward to have a career with Medley, you may explore our current opportunities
or send us your resume for openings at hr@medleylab.com
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