Shift Incharge - Navi Mumbai, Maharashtra, India - Reliance Life Sciences
Description
Posted Date:
- 20 Feb 2022
Function/Business Area: - Life Sciences
Location: - DALC
- Navi Mumbai
Responsibilities: - Completion of assigned projects as per timelines
- Adhering to process SOP
- Timely completion of documentation
- Adhering to safety risk compliance
- Execution of all process related activities
- To train the people in process
- Ensure proper documentation and 24/7 audit readiness
- Savings against allocated costs
- Quality of work execution
- External and internal customer management
- Knowledge about industry, current trends, new developments
- Vendor relations
Objective:
To ensure,
facilitate to bio similars drug product manufacturing and timely completion of drug product manufacturing process.
Essential Job Functions:
Plan & Execution of product manufacturing:
To facilitate Operation & changeover of process systems, debottlenecking of process hurdles
Regular interaction with Operation team, QAD and supporting functions to achieve the desired manufacturing activities
Focus on plant goals in order to attain expected products over all batch yield
Coordinate and monitor the manufacturing schedule to ensure proper utilisation of process units, utilities etc.
Hands on experience with vial filling line ,Pre filled syringe line and lyophilser process ,
High preference will be given to person has experience with Grohninger vial and pre filled syringes line and EDWRDS Lyophilisers
Any international filling line systems experience also preferable
(Ex:
Baush & strobble, Seidenadar Germany, Optima, steriline, Spami Italy filling lines)
Exposure on the following lyophiliser system would be preferable
Edwards
- Germany, Usifroid USA, Telstar
- Spain, True king or Tofflon China,
Review & monitoring:
To ensure the preparation of the cleaning / disinfectant solution and cleaning/fumigation of area/equipment as per the schedule and respective SOPs.
To ensure that on
- line entries in GMP documents like BMRs, BPRs, log-books etc. are performed as per Good Documentation Practice.
To ensure that all documents are updated/revised periodically to meet cGMP standards and as per QAD requirement
Ability to mainly evaluate schedule in accordance to manufacturing processes, and determine the most efficient method of accomplishing goals in order to meet the targets
Supervise, coach and train new and current employees (i.e. job, safety, etc.) to meet performance expectations by providing strong leadership skill set.
GMP compliance, Validation and audit readiness
To co-ordinate and support for timely completion of calibration, preventive maintenance, qualification/ validation revalidation of process units as per schedule.
Process systems and manufacturing area readiness for GMP.FDA,WHO and international audits
Preparation of BMR's and BPR's
Validation protocols preparation and its execution
Having USFDA ,ENVISA,ENVIMA audits experience would be added advantage
Safety Requirements:
Carrying out activities related to Occupational Health, Safety and Environment Management as per SOP
Awareness/Knowledge on the consequences of not following Standard Operating Procedures related to Occupational Health, Safety and Environment Management
Position requirements
Post graduate in microbiology/ biotechnology or B Pharm having minimum 6-8 years' experience in biotech injectable manufacturing domain or any OLD ( oral liquid dosage) and SVP (Small volume parenteral) manufacturing domain
Demonstrated ability to effectively supervise, lead and build relationships at all levels within the company.
Self-motivated; has accurate self-insight; builds team spirit by teaching and, maintains a positive disposition and persuasive.
Education Requirement:
- Graduation / Post Graduation
Experience Requirement:
- 58 years of relevant experience
Skills & Competencies:
Skills:
- Communication skills
- Documentation skills
- Computer skills
- Negotiation skills
- Problem solving skills
Core RIL Competencies:
- Passion to excel
- Entrepreneurial Mindset
- Managing Ambiguity
- Detail Orientation
- Lifelong Learning
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