About our client
Strides creates a work environment characterized by an open, entrepreneurial culture that fosters creativity and innovation. Within the rigor of an exciting and challenging industry, employees have an opportunity to work with partners in some of the world’s leading pharmaceutical companies, the best talent, and associate themselves with an organization that is recognized for path-breaking initiatives and adherence to the highest standards of ethics and integrity.
As multinational company, Strides is committed to a culture of diversity, reflected in a substantial and varied workforce across the globe. Employment decisions at Strides are based solely on merit, qualifications and abilities, ensuring a strict anti-discrimination policy based on gender, race, colour, nationality, sexual preference, marital status, age, disability, religion or employment status.
Strides recognizes the demands of the current work environment and importance of maintain a balance between personal and professional responsibilities and aspirations. To that end, their HR policies are designed to provide flexibility and help employees lead a more fulfilled life. Flexi time options, state of art gyms, a cricket club, runners club and artists groups are just some of the facilities available to all Stridians. The company also operates a "We Care" programme exclusively developed to address the wellness and health needs of employees through sessions conducted by doctors at Strides facilities.
Strides also has generous Rewards and Recognition Policies like the Leadership Incentive Compensation Plan, the Employee Stock Ownership Plan, the Long Service Award and Cash Award, all ensure that employees across all hierarchies within the company feel valued, motivated, and fulfilled by their work.
- Manage and schedule quality activities performed by QA Associates (batch record stage review, production quality inspection/ sampling /testing, etc.
- Raw Material/Packaging Component/Bulk Drug Product Release.
- Manage and coordinate raw material sampling/ release and bulk products review/release performed by QA Associates.
- Manage and coordinate equipment swabbing and release performed by QA Associates.
- Oversee liquid retains sample management and APR review.
- Provide expertise to operations to resolve floor issues, implement corrections, and assure deviations are opened.
- Collaborate with various departments to meet quality requirements and fulfill business needs.
- Provides manager with quality indicator data derived from supporting systems such as CME.
- Coordinates interdepartmental activities with QC, Supply Chain and Operations to meet business needs.
- Responsible for quarantining/rejecting product due to investigations disposition, field alerts, recalls, etc.
- Responsible for overseeing movement of controlled substance within their designated facility to and from secured location.
- Back up reviewer and approver of master packaging records in support of operations.
- Back up QA reviewer of environmental monitoring alarms.
- Back up for executed packaging and manufacturing batch record review.
- Author and review SOPs relevant to the job duties.
- Initiate deviation reports and supports investigative process.
- Monitor manufacturing and packaging processes to assure cGMP compliance and adherence to company SOPs.
- Assist internal quality initiatives and internal audits as required; assist as needed with FDA inspections.
- Provides guidance, training, cross-training, coaching and work assignments for QA Associates.
- Selects, develops, evaluates personnel to ensure efficient operation of QA function.
- Bachelor’s degree in Chemistry, Life Science, or related field.
- 7+ years of related experience in in a cGMP/pharmaceutical environments or equivalent.
- 2+ years’ supervisory experience.
- Experienced in training techniques.
- Understanding of cGMP principles, solid dosage manufacturing and packaging, DEA regulations
- Solid understanding and use of ANSI sampling techniques and principles.
- Intermediate computer skills.
Skills & Abilities:
- Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
- Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.
- Customer Service - Manages difficult or emotional customer situations; responds promptly to customer needs; solicits customer feedback to improve service; responds to requests for service and assistance; meets commitments.
- Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
- Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
- Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
- Able to effectively handle conflict/resolution situations between different departments and inter-department.
- Able to analyze and troubleshoot problems.