Shift Incharge

**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 entire manufacturing activities to be performed as per respective SOP's /guidelines

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.

Ensure that safety, Good Manufacturing Practices (GMPs) and sanitation policies and procedures are met.

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**:

- 5-8 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

.