zentiva
Website:
zentiva.com
Job details:
JOB TITLE Assistant Manager- Quality Control, Chemistry
Requirements
Education / Experience Post Graduate in Science (Organic or Analytical Chemistry ) 8 to 10 years in chemical & instrumental testing laboratory with exposure to GMP, GLP.
Technical skills &
Competencies / Language
- Technical competence
- Leadership skills
- Analytical ability
- Planning ability
- Communication skills
- Problem solving
Job Purpose
Generic To perform QC activities in order to ensure quality of products and services and maintain related documentation to adhere to Quality operations and regulatory requirements. All above activity shall be done living Group’s Values and Code of Ethics.
Key Accountabilities
1.1. Performing and organizing timely analysis of finished goods, stability samples, raw material, intermediate
and other samples for Chemistry.
1.2. Performing and organizing analysis of market complaints, Stability, process validation, Cleaning
Validation samples.
2.1. Performing and organizing calibration / maintenance of lab. Equipment and assisting for the qualification
of laboratory equipment.
2.2. Reviewing pharmacopeias for specification preparation.
2.3. Preparing SOPs, Formats, Specification, Analytical Test Record and other documents.
2.4. Managing reference standards, working standards, Laboratory chemicals & reagents.
2.5. Managing instrument laboratory with reference to spares, maintenance etc.
2.6. Managing Control Samples and related record.
2.7. Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products
and bulk medical device.
2.8. Investigating out of specification results, retesting and review the analysis records.
2.9. Maintaining & reviewing laboratory raw data and log book related to testing activity.
2.10. Responsible for reviewing the chromatographic data.
2.11. Management of LIMS and static data
- Quality, HSE and Compliance
3.1. Adhere to current GMP guidelines
3.2. Following ALCOA+++ practices during documentation and related activities 3.3. Compliance to local and international HSE norms
3.4. Regulatory compliance
3.5. ISO 14000 related activities
3.6. Regular Pharmacopoeia and regulatory requirement review for compliance 3.7. To participate in any regulatory/Customer inspection takes place at the site 3.8. Training of self and subordinates on quality and HSE systems
4.1. Preparing protocol and report for Analytical Method validation, cleaning validation and performing / organizing the validation exercise as per the protocol. 5. Management of laboratory Consumables
5.1. Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, glassware and printed material.
5.2. Maintaining stock of laboratory chemicals in line with budget
6.1. Coordinating with production, and warehouse for analytical activities.
7.1. Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
7.2. Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
7.3. Performing internal quality audit as a “Qualified Internal Auditor” during internal Quality Audit abiding the internal quality audit schedule.
7.4. Train the subordinate for laboratory related jobs.
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